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.
6 linked reportsInjury 6
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
3.25
2019-02
0
2.69
2019-03
0
2.71
2019-04
0
2.69
2019-05
0
2.18
2019-06
0
1.92
2019-07
0
1.96
2019-08
0
2.05
2019-09
0
2.34
2019-10
0
2.39
2019-11
0
1.91
2019-12
0
2.27
2020-01
0
2.54
2020-02
0
2.52
2020-03
0
3.29
2020-04
0
2.2
2020-05
0
2.7
2020-06
0
2.29
2020-07
0
3.56
2020-08
0
3.81
2020-09
0
3.38
2020-10
0
3.69
2020-11
0
3.68
2020-12
0
4.52
2021-01
0
3.93
2021-02
0
3.14
2021-03
0
2.46
2021-04
0
2.44
2021-05
0
3.73
2021-06
0
3.25
2021-07
0
3.15
2021-08
0
2.96
2021-09
0
3.23
2021-10
0
2.65
2021-11
0
3.07
2021-12
0
3.11
2022-01
0
2.73
2022-02
0
3.47
2022-03
0
2.59
2022-04
0
3.07
2022-05
0
2.64
2022-06
0
2.36
2022-07
0
2.28
2022-08
0
2.41
2022-09
0
2.17
2022-10
0
2.49
2022-11
0
2.21
2022-12
0
2.22
2023-01
0
1.81
2023-02
0
2.02
2023-03
0
2.22
2023-04
0
2.07
2023-05
0
2.36
2023-06
0
2.24
2023-07
0
2.1
2023-08
1
2.09
2023-09
0
2.04
2023-10
0
1.6
2023-11
0
1.66
2023-12
0
1.6
2024-01
0
1.69
2024-02
0
1.94
2024-03
0
2
2024-04
0
1.76
2024-05
0
2.21
2024-06
0
1.98
2024-07
1
1.71
2024-08
0
1.99
2024-09
0
2.02
2024-10
0
1.68
2024-11
2
1.58
2024-12
0
1.57
2025-01
0
1.57
2025-02
0
1.5
2025-03
0
1.68
2025-04
2
1.82
2025-05
0
1.53
2025-06
0
1.8
2025-07
0
1.71
2025-08
0
1.58
2025-09
0
1.78
2025-10
0
1.77
2025-11
0
1.91
2025-12
0
1.96
2026-01
0
2.07
2026-02
0
1.61
2026-03
0
2.16
2026-04
0
1.82
2026-05
0
1.95
2026-06
0
1.72
This device (reports/month)Average device in JDG, JDI (reports/device/month)
Failure-mode summaryAI-generated
6 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.