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Adverse-event reports (MAUDE)

Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

470 linked reportsMalfunction 432Injury 38
81523302019-01: 11 reports for this device; peer average 21.43/device2019-02: 17 reports for this device; peer average 18.76/device2019-03: 30 reports for this device; peer average 17.38/device2019-04: 24 reports for this device; peer average 19.33/device2019-05: 15 reports for this device; peer average 13.96/device2019-06: 17 reports for this device; peer average 13.78/device2019-07: 20 reports for this device; peer average 13.72/device2019-08: 11 reports for this device; peer average 17.95/device2019-09: 14 reports for this device; peer average 18.36/device2019-10: 26 reports for this device; peer average 18.02/device2019-11: 14 reports for this device; peer average 15.86/device2019-12: 16 reports for this device; peer average 17.13/device2020-01: 9 reports for this device; peer average 16.71/device2020-02: 25 reports for this device; peer average 20.62/device2020-03: 6 reports for this device; peer average 18.02/device2020-04: 11 reports for this device; peer average 17.91/device2020-05: 7 reports for this device; peer average 18.04/device2020-06: 6 reports for this device; peer average 23/device2020-07: 7 reports for this device; peer average 18.62/device2020-08: 10 reports for this device; peer average 16.63/device2020-09: 4 reports for this device; peer average 17.67/device2020-10: 11 reports for this device; peer average 14.94/device2020-11: 11 reports for this device; peer average 24.82/device2020-12: 7 reports for this device; peer average 22.21/device2021-01: 10 reports for this device; peer average 15.96/device2021-02: 7 reports for this device; peer average 16.49/device2021-03: 11 reports for this device; peer average 19.12/device2021-04: 5 reports for this device; peer average 15.19/device2021-05: 6 reports for this device; peer average 15.95/device2021-06: 10 reports for this device; peer average 19/device2021-07: 9 reports for this device; peer average 16.37/device2021-08: 14 reports for this device; peer average 18/device2021-09: 10 reports for this device; peer average 23.38/device2021-10: 8 reports for this device; peer average 22.3/device2021-11: 7 reports for this device; peer average 22.43/device2021-12: 5 reports for this device; peer average 30.38/device2022-01: 6 reports for this device; peer average 17.63/device2022-02: 3 reports for this device; peer average 20.54/device2022-03: 1 reports for this device; peer average 24.04/device2022-04: 2 reports for this device; peer average 20.64/device2022-05: 0 reports for this device; peer average 19.24/device2022-06: 4 reports for this device; peer average 25.56/device2022-07: 8 reports for this device; peer average 14.88/device2022-08: 3 reports for this device; peer average 22.97/device2022-09: 0 reports for this device; peer average 23.4/device2022-10: 4 reports for this device; peer average 24.15/device2022-11: 1 reports for this device; peer average 27.41/device2022-12: 2 reports for this device; peer average 24.35/device2023-01: 0 reports for this device; peer average 25.31/device2023-02: 0 reports for this device; peer average 18/device2023-03: 0 reports for this device; peer average 17.71/device2023-04: 0 reports for this device; peer average 24.73/device2023-05: 0 reports for this device; peer average 20.82/device2023-06: 4 reports for this device; peer average 21.58/device2023-07: 1 reports for this device; peer average 19.96/device2023-08: 0 reports for this device; peer average 18.26/device2023-09: 0 reports for this device; peer average 17.14/device2023-10: 0 reports for this device; peer average 20.16/device2023-11: 0 reports for this device; peer average 16.89/device2023-12: 0 reports for this device; peer average 23.32/device2024-01: 0 reports for this device; peer average 18.64/device2024-02: 0 reports for this device; peer average 16.59/device2024-03: 0 reports for this device; peer average 13.58/device2024-04: 0 reports for this device; peer average 14.97/device2024-05: 0 reports for this device; peer average 12.78/device2024-06: 0 reports for this device; peer average 18.13/device2024-07: 0 reports for this device; peer average 13.33/device2024-08: 0 reports for this device; peer average 15.55/device2024-09: 0 reports for this device; peer average 17.28/device2024-10: 0 reports for this device; peer average 12.35/device2024-11: 0 reports for this device; peer average 11.41/device2024-12: 0 reports for this device; peer average 16.73/device2025-01: 0 reports for this device; peer average 13.56/device2025-02: 0 reports for this device; peer average 13.63/device2025-03: 0 reports for this device; peer average 12.54/device2025-04: 0 reports for this device; peer average 11.36/device2025-05: 0 reports for this device; peer average 16.95/device2025-06: 0 reports for this device; peer average 13.06/device2025-07: 0 reports for this device; peer average 18/device2025-08: 0 reports for this device; peer average 17.47/device2025-09: 0 reports for this device; peer average 14.61/device2025-10: 0 reports for this device; peer average 11.11/device2025-11: 0 reports for this device; peer average 10.08/device2025-12: 0 reports for this device; peer average 16.79/device2026-01: 0 reports for this device; peer average 14.68/device2026-02: 0 reports for this device; peer average 15.06/device2026-03: 0 reports for this device; peer average 11.26/device2026-04: 0 reports for this device; peer average 12.27/device2026-05: 0 reports for this device; peer average 12.42/device2026-06: 0 reports for this device; peer average 16.46/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-011121.43
2019-021718.76
2019-033017.38
2019-042419.33
2019-051513.96
2019-061713.78
2019-072013.72
2019-081117.95
2019-091418.36
2019-102618.02
2019-111415.86
2019-121617.13
2020-01916.71
2020-022520.62
2020-03618.02
2020-041117.91
2020-05718.04
2020-06623
2020-07718.62
2020-081016.63
2020-09417.67
2020-101114.94
2020-111124.82
2020-12722.21
2021-011015.96
2021-02716.49
2021-031119.12
2021-04515.19
2021-05615.95
2021-061019
2021-07916.37
2021-081418
2021-091023.38
2021-10822.3
2021-11722.43
2021-12530.38
2022-01617.63
2022-02320.54
2022-03124.04
2022-04220.64
2022-05019.24
2022-06425.56
2022-07814.88
2022-08322.97
2022-09023.4
2022-10424.15
2022-11127.41
2022-12224.35
2023-01025.31
2023-02018
2023-03017.71
2023-04024.73
2023-05020.82
2023-06421.58
2023-07119.96
2023-08018.26
2023-09017.14
2023-10020.16
2023-11016.89
2023-12023.32
2024-01018.64
2024-02016.59
2024-03013.58
2024-04014.97
2024-05012.78
2024-06018.13
2024-07013.33
2024-08015.55
2024-09017.28
2024-10012.35
2024-11011.41
2024-12016.73
2025-01013.56
2025-02013.63
2025-03012.54
2025-04011.36
2025-05016.95
2025-06013.06
2025-07018
2025-08017.47
2025-09014.61
2025-10011.11
2025-11010.08
2025-12016.79
2026-01014.68
2026-02015.06
2026-03011.26
2026-04012.27
2026-05012.42
2026-06016.46
This device (reports/month)Average device in LFL (reports/device/month)
Failure-mode summaryAI-generated

40 linked report narratives available — no AI summary generated yet.

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2023-07-031717344-2023-00805MalfunctionAvailableexact di
2023-06-301717344-2023-00779MalfunctionAvailableexact di
2023-06-301717344-2023-00774MalfunctionAvailableexact di
2023-06-291717344-2023-00785MalfunctionAvailableexact di
2023-06-281717344-2023-00783MalfunctionAvailableexact di
2022-12-281717344-2022-01606MalfunctionAvailableexact di
2022-12-011717344-2022-01477MalfunctionAvailableexact di
2022-11-211717344-2022-01429InjuryAvailableexact di
2022-10-291717344-2022-01337InjuryAvailableexact di
2022-10-211717344-2022-01307InjuryAvailableexact di
2022-10-121717344-2022-01276MalfunctionAvailableexact di
2022-10-051717344-2022-01240MalfunctionAvailableexact di
2022-08-261717344-2022-01033MalfunctionAvailableexact di
2022-08-151717344-2022-00975MalfunctionAvailableexact di
2022-08-111717344-2022-00963MalfunctionAvailableexact di

Showing the most recent 200 of 470 linked reports.

Showing 1–15 of 200
Regulatory clearances
  • 510(k)K101797Substantially equivalent (SESE) · 2011-02-24clearance family

Predicate lineage

Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2025-07-16NAINo action indicatedCovidien LLC0
2025-07-16NAINo action indicatedCovidien LLC0
2024-11-21NAINo action indicatedCovidien, LP0
2024-11-21NAINo action indicatedCovidien, LP0
2022-11-18VAIVoluntary action indicatedCovidien LP1
2022-11-18VAIVoluntary action indicatedCovidien LP1
2022-09-08VAIVoluntary action indicatedCovidien0
2022-09-08VAIVoluntary action indicatedCovidien0
2022-04-28OAIOfficial action indicatedCovidien2
2022-04-28OAIOfficial action indicatedCovidien2
2020-02-28VAIVoluntary action indicatedCovidien, LP1
2020-02-28VAIVoluntary action indicatedCovidien, LP1
2018-09-19NAINo action indicatedCovidien0
2018-09-19NAINo action indicatedCovidien0
2017-09-22VAIVoluntary action indicatedCovidien, LLC2
2017-09-22VAIVoluntary action indicatedCovidien, LLC2
2017-08-09NAINo action indicatedCovidien0
2017-08-09NAINo action indicatedCovidien0
2016-10-31NAINo action indicatedCovidien0
2016-10-31NAINo action indicatedCovidien0
2012-06-14WLWarning LetterCovidien, LP—
2012-06-14WLWarning LetterCovidien, LP—
2011-10-04WLWarning LetterOridion Medical 1987 Ltd.—
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