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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.

30 linked reportsMalfunction 18Injury 12
24572019-01: 0 reports for this device; peer average 1/device2019-04: 0 reports for this device; peer average 1.5/device2019-05: 0 reports for this device; peer average 1.5/device2019-06: 0 reports for this device; peer average 2/device2019-07: 0 reports for this device; peer average 1/device2019-08: 0 reports for this device; peer average 1.4/device2019-10: 0 reports for this device; peer average 1.5/device2019-11: 0 reports for this device; peer average 2/device2019-12: 0 reports for this device; peer average 1/device2020-01: 0 reports for this device; peer average 1.17/device2020-04: 0 reports for this device; peer average 1/device2020-05: 0 reports for this device; peer average 1.5/device2020-06: 0 reports for this device; peer average 1/device2020-07: 0 reports for this device; peer average 1/device2020-08: 0 reports for this device; peer average 1/device2020-11: 0 reports for this device; peer average 2/device2020-12: 0 reports for this device; peer average 1/device2021-01: 0 reports for this device; peer average 1.29/device2021-02: 0 reports for this device; peer average 2.17/device2021-03: 0 reports for this device; peer average 1.17/device2021-04: 0 reports for this device; peer average 1/device2021-05: 0 reports for this device; peer average 2.8/device2021-06: 0 reports for this device; peer average 2.5/device2021-07: 0 reports for this device; peer average 1.5/device2021-08: 0 reports for this device; peer average 1.75/device2021-09: 0 reports for this device; peer average 4.2/device2021-10: 0 reports for this device; peer average 2.5/device2021-11: 0 reports for this device; peer average 3.14/device2021-12: 0 reports for this device; peer average 2.57/device2022-01: 0 reports for this device; peer average 1.5/device2022-02: 0 reports for this device; peer average 1.17/device2022-03: 6 reports for this device; peer average 2.29/device2022-04: 0 reports for this device; peer average 3.5/device2022-05: 6 reports for this device; peer average 3.5/device2022-06: 0 reports for this device; peer average 1.83/device2022-07: 0 reports for this device; peer average 2/device2022-08: 0 reports for this device; peer average 3.8/device2022-09: 0 reports for this device; peer average 2.13/device2022-10: 0 reports for this device; peer average 1.43/device2022-11: 0 reports for this device; peer average 1.5/device2022-12: 0 reports for this device; peer average 1/device2023-01: 0 reports for this device; peer average 2.67/device2023-02: 0 reports for this device; peer average 1/device2023-03: 0 reports for this device; peer average 5/device2023-04: 0 reports for this device; peer average 1.67/device2023-05: 0 reports for this device; peer average 2/device2023-06: 0 reports for this device; peer average 2/device2023-07: 0 reports for this device; peer average 1.2/device2023-08: 0 reports for this device; peer average 2.33/device2023-09: 0 reports for this device; peer average 1.4/device2023-10: 0 reports for this device; peer average 1.22/device2023-11: 0 reports for this device; peer average 5.67/device2023-12: 0 reports for this device; peer average 2/device2024-01: 0 reports for this device; peer average 1.6/device2024-02: 0 reports for this device; peer average 1.33/device2024-03: 0 reports for this device; peer average 1.25/device2024-04: 0 reports for this device; peer average 1.44/device2024-05: 0 reports for this device; peer average 1.6/device2024-07: 0 reports for this device; peer average 1/device2024-08: 6 reports for this device; peer average 2.43/device2024-09: 0 reports for this device; peer average 1.22/device2024-10: 0 reports for this device; peer average 2.13/device2024-11: 0 reports for this device; peer average 1.77/device2024-12: 0 reports for this device; peer average 4.75/device2025-01: 0 reports for this device; peer average 1.5/device2025-02: 0 reports for this device; peer average 1.67/device2025-03: 0 reports for this device; peer average 7/device2025-04: 0 reports for this device; peer average 5.4/device2025-05: 0 reports for this device; peer average 1.4/device2025-06: 0 reports for this device; peer average 2.86/device2025-07: 0 reports for this device; peer average 3.38/device2025-08: 0 reports for this device; peer average 1/device2025-09: 0 reports for this device; peer average 1.33/device2025-10: 0 reports for this device; peer average 1.67/device2025-11: 0 reports for this device; peer average 1.56/device2025-12: 0 reports for this device; peer average 2.29/device2026-01: 6 reports for this device; peer average 3/device2026-02: 6 reports for this device; peer average 5.25/device2026-03: 0 reports for this device; peer average 1/device2026-04: 0 reports for this device; peer average 1/device2026-05: 0 reports for this device; peer average 3/device2026-06: 0 reports for this device; peer average 3/device01040506070810111201040506070811120102030405060708091011120102030405060708091011120102030405060708091011120102030405070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101
2019-0401.5
2019-0501.5
2019-0602
2019-0701
2019-0801.4
2019-1001.5
2019-1102
2019-1201
2020-0101.17
2020-0401
2020-0501.5
2020-0601
2020-0701
2020-0801
2020-1102
2020-1201
2021-0101.29
2021-0202.17
2021-0301.17
2021-0401
2021-0502.8
2021-0602.5
2021-0701.5
2021-0801.75
2021-0904.2
2021-1002.5
2021-1103.14
2021-1202.57
2022-0101.5
2022-0201.17
2022-0362.29
2022-0403.5
2022-0563.5
2022-0601.83
2022-0702
2022-0803.8
2022-0902.13
2022-1001.43
2022-1101.5
2022-1201
2023-0102.67
2023-0201
2023-0305
2023-0401.67
2023-0502
2023-0602
2023-0701.2
2023-0802.33
2023-0901.4
2023-1001.22
2023-1105.67
2023-1202
2024-0101.6
2024-0201.33
2024-0301.25
2024-0401.44
2024-0501.6
2024-0701
2024-0862.43
2024-0901.22
2024-1002.13
2024-1101.77
2024-1204.75
2025-0101.5
2025-0201.67
2025-0307
2025-0405.4
2025-0501.4
2025-0602.86
2025-0703.38
2025-0801
2025-0901.33
2025-1001.67
2025-1101.56
2025-1202.29
2026-0163
2026-0265.25
2026-0301
2026-0401
2026-0503
2026-0603
This device (reports/month)Average device in CBI (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2026-02-269610691-2026-00006InjuryAvailablecatalog number
2026-02-261220828-2026-00006InjuryAvailablecatalog number
2026-01-069610691-2026-00001MalfunctionAvailablecatalog number
2026-01-061220828-2026-00001MalfunctionAvailableexact di
2024-08-289610691-2024-00016MalfunctionAvailablecatalog number
2024-08-281220828-2024-00017MalfunctionAvailablecatalog number
2022-05-079610691-2022-00005MalfunctionAvailablecatalog number
2022-05-071220828-2022-00006InjuryAvailablecatalog number
2022-03-111220828-2022-00005InjuryAvailablecatalog number
2022-03-109610691-2022-00004MalfunctionAvailablecatalog number

Showing the most recent 10 of 30 linked reports.

Regulatory clearances

None linked.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2016-05-20VAIVoluntary action indicatedAMBU Limited0
2016-04-15VAIVoluntary action indicatedAmbu Sdn. Bhd.0
2013-11-07VAIVoluntary action indicatedAMBU Limited2
2013-09-19VAIVoluntary action indicatedAmbu Sdn. Bhd.5
2013-06-19NAINo action indicatedAmbu A/S0
2013-06-19NAINo action indicatedAmbu A/S0
2011-06-02VAIVoluntary action indicatedAMBU Limited2
2010-02-09NAINo action indicatedAmbu A/S0
2010-02-09NAINo action indicatedAmbu A/S0
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