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.
9 linked reportsInjury 9
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
0
2
2019-02
0
2.27
2019-03
0
1.53
2019-04
0
2.1
2019-05
0
1.63
2019-06
0
2.06
2019-07
0
1.83
2019-08
0
1.4
2019-09
0
1.83
2019-10
0
2
2019-11
0
1.5
2019-12
0
2.4
2020-01
0
2.07
2020-02
0
3
2020-03
0
2.53
2020-04
0
2.33
2020-05
0
1.5
2020-06
0
1.71
2020-07
0
1.88
2020-08
0
1.25
2020-09
0
2
2020-10
0
1.17
2020-11
0
1.6
2020-12
0
2
2021-01
0
1.81
2021-02
0
2
2021-03
0
1.33
2021-04
0
1.38
2021-05
0
1.92
2021-06
0
2.67
2021-07
0
1.33
2021-08
0
1
2021-09
0
1.29
2021-10
0
1.31
2021-11
0
1.14
2021-12
0
2.33
2022-01
0
2.43
2022-02
0
1.86
2022-03
0
1.5
2022-04
0
1.4
2022-05
0
1.82
2022-06
0
1
2022-07
0
1.6
2022-08
0
2.64
2022-09
0
2.73
2022-10
0
2.43
2022-11
0
1.78
2022-12
0
1.5
2023-01
0
2.93
2023-02
0
2.33
2023-03
0
2.2
2023-04
0
8.25
2023-05
0
2.94
2023-06
0
2.18
2023-07
0
2.77
2023-08
0
2.08
2023-09
0
2.29
2023-10
0
2.2
2023-11
0
1.67
2023-12
0
1.73
2024-01
0
1.64
2024-02
0
1.2
2024-03
0
1.55
2024-04
0
1.78
2024-05
0
1.69
2024-06
0
1
2024-07
0
1
2024-08
0
1.8
2024-09
0
1.67
2024-10
0
2
2024-11
0
1.43
2024-12
0
1.86
2025-01
0
2.75
2025-02
0
2.13
2025-03
0
1.5
2025-04
1
1.29
2025-05
4
2.13
2025-06
0
1.33
2025-07
0
4.5
2025-08
0
1.8
2025-09
2
1.5
2025-10
0
1.71
2025-11
0
2.17
2025-12
0
2.33
2026-01
0
2.13
2026-02
0
1.33
2026-03
0
3.67
2026-04
0
2.8
2026-05
2
1.33
2026-06
0
2.75
This device (reports/month)Average device in FTM (reports/device/month)
Failure-mode summaryAI-generated
9 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
Date
Report #
Type
Narrative
Link basis
2026-05-27
1000306051-2026-00049
Injury
Available
catalog number
2026-05-27
1000306051-2026-00048
Injury
Available
catalog number
2025-09-10
1000306051-2025-00087
Injury
Available
catalog number
2025-05-20
1000306051-2025-00057
Injury
Available
catalog number
2025-05-20
1000306051-2025-00056
Injury
Available
catalog number
2025-04-04
1000306051-2025-00044
Injury
Available
catalog number
Showing the most recent 6 of 9 linked reports.
Regulatory clearances
510(k)K162752Substantially equivalent (SESE) · 2017-02-24clearance family
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.