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.
3 linked reportsInjury 3
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
2.02
2019-02
0
1.76
2019-03
0
1.81
2019-04
0
1.79
2019-05
0
1.89
2019-06
0
1.9
2019-07
0
1.75
2019-08
0
3.16
2019-09
0
1.71
2019-10
0
2.23
2019-11
0
2.05
2019-12
0
1.71
2020-01
0
3.12
2020-02
0
1.98
2020-03
0
1.88
2020-04
0
1.62
2020-05
0
2.02
2020-06
0
2.04
2020-07
0
2
2020-08
0
1.7
2020-09
0
2.23
2020-10
0
2.24
2020-11
0
2.59
2020-12
0
2.03
2021-01
0
1.69
2021-02
0
2.01
2021-03
0
2.2
2021-04
0
1.82
2021-05
0
2.16
2021-06
0
2.51
2021-07
0
2.14
2021-08
0
2.18
2021-09
0
1.86
2021-10
0
2.59
2021-11
0
2.01
2021-12
0
2.32
2022-01
0
2.13
2022-02
0
2.04
2022-03
0
1.73
2022-04
0
1.62
2022-05
0
1.88
2022-06
0
2.06
2022-07
0
3.04
2022-08
0
2.06
2022-09
0
2.69
2022-10
0
1.56
2022-11
0
2
2022-12
0
2.07
2023-01
0
2.17
2023-02
0
2.09
2023-03
0
2.25
2023-04
0
1.71
2023-05
0
1.85
2023-06
0
1.56
2023-07
0
1.87
2023-08
0
1.93
2023-09
0
2.43
2023-10
0
2.28
2023-11
0
2.19
2023-12
0
1.71
2024-01
0
2.33
2024-02
0
2.06
2024-03
0
3.4
2024-04
0
1.65
2024-05
0
2.73
2024-06
0
3.37
2024-07
0
2.07
2024-08
0
1.74
2024-09
3
2.77
2024-10
0
2.06
2024-11
0
1.64
2024-12
0
1.63
2025-01
0
2.13
2025-02
0
2.42
2025-03
0
2.26
2025-04
0
2.11
2025-05
0
2.5
2025-06
0
2.28
2025-07
0
2.07
2025-08
0
1.91
2025-09
0
1.98
2025-10
0
1.83
2025-11
0
1.98
2025-12
0
2.47
2026-01
0
2.42
2026-02
0
2.29
2026-03
0
2.55
2026-04
0
1.8
2026-05
0
2.51
2026-06
0
3.99
This device (reports/month)Average device in KWQ, ODP, OVE (reports/device/month)
Failure-mode summaryAI-generated
3 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.