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.
2 linked reportsInjury 2
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
6.74
2019-02
0
4.62
2019-03
0
4.67
2019-04
0
6.09
2019-05
0
5.14
2019-06
0
5.38
2019-07
0
5.99
2019-08
0
6.7
2019-09
0
5.17
2019-10
0
5.8
2019-11
0
5.56
2019-12
0
5.52
2020-01
0
4.67
2020-02
0
5.7
2020-03
0
5.96
2020-04
0
4.16
2020-05
0
3.8
2020-06
0
4.98
2020-07
0
6.35
2020-08
0
4.51
2020-09
0
5.67
2020-10
0
5.37
2020-11
0
5.12
2020-12
0
5.56
2021-01
0
5.57
2021-02
0
4.9
2021-03
0
6.02
2021-04
0
5.29
2021-05
0
5.33
2021-06
0
6.15
2021-07
0
5.53
2021-08
0
4.88
2021-09
0
5.31
2021-10
0
6.14
2021-11
0
5.89
2021-12
0
6.24
2022-01
0
5.35
2022-02
0
5.43
2022-03
0
6.03
2022-04
0
5.54
2022-05
0
6.37
2022-06
0
6.49
2022-07
0
4.77
2022-08
0
4.7
2022-09
0
4.91
2022-10
0
4.7
2022-11
0
4.52
2022-12
0
4.16
2023-01
0
5.44
2023-02
0
4.53
2023-03
0
4.98
2023-04
0
4.56
2023-05
0
5.08
2023-06
0
4.65
2023-07
0
4.72
2023-08
0
4.54
2023-09
0
5.23
2023-10
0
5.29
2023-11
0
4.54
2023-12
0
4.86
2024-01
0
5.68
2024-02
0
5.32
2024-03
0
6.14
2024-04
0
6
2024-05
0
5.99
2024-06
0
5.42
2024-07
0
5.04
2024-08
0
5.08
2024-09
0
5.26
2024-10
0
5.84
2024-11
0
5.01
2024-12
0
5.06
2025-01
0
5.09
2025-02
0
4.39
2025-03
0
6.01
2025-04
0
4.23
2025-05
0
4.88
2025-06
0
4.91
2025-07
0
4.92
2025-08
0
5.49
2025-09
0
5.27
2025-10
0
5.86
2025-11
0
7.1
2025-12
0
8.5
2026-01
0
7.37
2026-02
0
6.08
2026-03
0
6.57
2026-04
0
6.84
2026-05
2
8.06
2026-06
0
6.93
This device (reports/month)Average device in GEI, IYO, OUH (reports/device/month)
Failure-mode summaryAI-generated
2 linked report narratives available — no AI summary generated yet.
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.