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.
1 linked reportInjury 1
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
3.04
2019-02
0
1.81
2019-03
0
1.76
2019-04
0
2.23
2019-05
0
1.9
2019-06
0
1.98
2019-07
0
2.08
2019-08
0
2.12
2019-09
0
2.14
2019-10
0
1.93
2019-11
0
2.23
2019-12
0
2.7
2020-01
0
2.62
2020-02
0
2.1
2020-03
0
2.1
2020-04
0
2.18
2020-05
0
1.94
2020-06
0
2.23
2020-07
0
2.71
2020-08
0
2.7
2020-09
0
2.55
2020-10
0
2.59
2020-11
0
3.23
2020-12
0
3.06
2021-01
0
2.2
2021-02
0
2.5
2021-03
0
2.84
2021-04
0
3.1
2021-05
0
2.78
2021-06
0
2.42
2021-07
0
2.47
2021-08
0
2.4
2021-09
0
2.83
2021-10
0
2.65
2021-11
0
2.75
2021-12
0
2.8
2022-01
0
3.48
2022-02
0
2.55
2022-03
1
2.47
2022-04
0
2.4
2022-05
0
2.63
2022-06
0
2.41
2022-07
0
2.53
2022-08
0
2.7
2022-09
0
2.98
2022-10
0
3.17
2022-11
0
2.87
2022-12
0
4.86
2023-01
0
2.9
2023-02
0
2.88
2023-03
0
3.19
2023-04
0
3.04
2023-05
0
3.42
2023-06
0
3.26
2023-07
0
2.61
2023-08
0
2.62
2023-09
0
2.53
2023-10
0
2.62
2023-11
0
2.48
2023-12
0
2.95
2024-01
0
3.27
2024-02
0
2.22
2024-03
0
2.87
2024-04
0
2.71
2024-05
0
2.74
2024-06
0
2.87
2024-07
0
2.89
2024-08
0
2.43
2024-09
0
2.74
2024-10
0
2.7
2024-11
0
2.66
2024-12
0
3.28
2025-01
0
3.1
2025-02
0
2.72
2025-03
0
2.7
2025-04
0
2.98
2025-05
0
3.07
2025-06
0
2.86
2025-07
0
2.9
2025-08
0
3.03
2025-09
0
2.85
2025-10
0
3.15
2025-11
0
2.95
2025-12
0
3.81
2026-01
0
3.22
2026-02
0
3.44
2026-03
0
3.4
2026-04
0
3.22
2026-05
0
3.77
2026-06
0
3.49
This device (reports/month)Average device in HWC, MAI (reports/device/month)
Failure-mode summaryAI-generated
1 linked report narrative 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.