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
2.41
2019-02
0
1.93
2019-03
0
1.62
2019-04
0
1.95
2019-05
0
2.02
2019-06
0
1.97
2019-07
0
2.14
2019-08
0
2.58
2019-09
0
2.24
2019-10
0
2.7
2019-11
0
3.68
2019-12
0
2.75
2020-01
0
2.56
2020-02
0
2.07
2020-03
0
2.32
2020-04
0
1.74
2020-05
0
1.47
2020-06
0
2.58
2020-07
0
2.78
2020-08
0
2.79
2020-09
0
2.49
2020-10
1
2.95
2020-11
0
3.35
2020-12
0
3.77
2021-01
0
2.74
2021-02
0
3.22
2021-03
1
2.18
2021-04
0
2.17
2021-05
0
3.13
2021-06
0
2.99
2021-07
0
2.76
2021-08
0
2.62
2021-09
0
3.13
2021-10
0
2.39
2021-11
0
2.39
2021-12
0
2.67
2022-01
0
2.27
2022-02
0
2.59
2022-03
0
2.68
2022-04
0
2.61
2022-05
0
3.12
2022-06
0
2.22
2022-07
0
2.56
2022-08
3
2.2
2022-09
0
2.74
2022-10
0
2.32
2022-11
0
2.22
2022-12
0
1.98
2023-01
0
2.19
2023-02
0
2.13
2023-03
0
1.93
2023-04
0
2.08
2023-05
0
2.09
2023-06
0
2.22
2023-07
0
1.74
2023-08
0
1.67
2023-09
0
1.4
2023-10
0
1.51
2023-11
0
1.83
2023-12
0
1.55
2024-01
0
1.64
2024-02
0
1.65
2024-03
0
1.63
2024-04
0
1.64
2024-05
0
1.46
2024-06
0
1.57
2024-07
0
1.54
2024-08
0
1.57
2024-09
0
1.51
2024-10
0
1.64
2024-11
0
1.51
2024-12
0
1.6
2025-01
0
1.54
2025-02
0
1.47
2025-03
0
1.43
2025-04
0
1.52
2025-05
0
1.53
2025-06
0
1.46
2025-07
0
1.63
2025-08
0
1.39
2025-09
0
1.54
2025-10
0
1.48
2025-11
0
1.49
2025-12
0
1.66
2026-01
0
1.47
2026-02
0
1.47
2026-03
0
1.61
2026-04
0
1.47
2026-05
0
1.56
2026-06
0
1.47
This device (reports/month)Average device in HRY, HSX, KRR, NJD, NPJ, OIY (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.