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.
5 linked reportsInjury 5
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
3.78
2019-02
0
2.69
2019-03
0
3.27
2019-04
0
4.36
2019-05
0
2.23
2019-06
0
4.77
2019-07
0
4.32
2019-08
0
3
2019-09
0
2.67
2019-10
0
3.18
2019-11
0
2.72
2019-12
0
3.65
2020-01
0
3
2020-02
0
3.67
2020-03
0
3.65
2020-04
0
3.17
2020-05
0
2.3
2020-06
0
5
2020-07
0
2.04
2020-08
0
2.5
2020-09
0
2.26
2020-10
0
3.5
2020-11
0
3.14
2020-12
0
4.21
2021-01
0
2.25
2021-02
0
4.5
2021-03
0
3.95
2021-04
0
3.53
2021-05
0
2.67
2021-06
0
7.33
2021-07
0
10.76
2021-08
0
5.43
2021-09
0
5.22
2021-10
0
7.62
2021-11
0
5.4
2021-12
0
6.65
2022-01
0
5.95
2022-02
0
3.39
2022-03
0
9.28
2022-04
0
4
2022-05
0
4.85
2022-06
0
2.05
2022-07
0
3.76
2022-08
0
3.21
2022-09
0
3.18
2022-10
0
2.91
2022-11
0
3.7
2022-12
0
10.85
2023-01
0
20.62
2023-02
0
8.76
2023-03
0
11.74
2023-04
0
12.83
2023-05
3
16.68
2023-06
0
17.52
2023-07
0
11.38
2023-08
0
10.61
2023-09
0
9.27
2023-10
0
10.57
2023-11
0
9.06
2023-12
0
10.81
2024-01
0
8.47
2024-02
0
11.07
2024-03
0
11.65
2024-04
0
9.86
2024-05
0
11.83
2024-06
0
9.03
2024-07
0
9.7
2024-08
0
10.74
2024-09
0
12
2024-10
0
10.05
2024-11
0
7.97
2024-12
0
11.71
2025-01
0
9.85
2025-02
0
12.36
2025-03
0
9.44
2025-04
0
10.03
2025-05
0
9.39
2025-06
0
8.24
2025-07
0
9.1
2025-08
0
9.82
2025-09
2
8.97
2025-10
0
8
2025-11
0
9.32
2025-12
0
9.75
2026-01
0
11.85
2026-02
0
16.95
2026-03
0
7.96
2026-04
0
8.59
2026-05
0
5.76
2026-06
0
7.7
This device (reports/month)Average device in HIG, HIH (reports/device/month)
Failure-mode summaryAI-generated
5 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.