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
2.02
2019-02
0
1.83
2019-03
0
1.85
2019-04
0
1.83
2019-05
1
1.9
2019-06
0
1.98
2019-07
0
1.74
2019-08
0
2.82
2019-09
1
1.73
2019-10
0
2.06
2019-11
0
2.09
2019-12
0
1.72
2020-01
0
3.2
2020-02
0
1.98
2020-03
0
1.92
2020-04
0
1.63
2020-05
0
2.08
2020-06
0
2.11
2020-07
0
2.05
2020-08
0
1.79
2020-09
0
2.25
2020-10
0
2.38
2020-11
0
2.63
2020-12
0
2.03
2021-01
0
1.73
2021-02
0
2.04
2021-03
2
2.24
2021-04
0
1.88
2021-05
0
2.21
2021-06
0
1.98
2021-07
0
2.2
2021-08
0
2.22
2021-09
0
1.86
2021-10
0
2.63
2021-11
0
2.05
2021-12
0
2.48
2022-01
0
2.28
2022-02
0
2.12
2022-03
1
1.74
2022-04
0
1.65
2022-05
0
1.88
2022-06
0
2.11
2022-07
1
3.19
2022-08
0
2.14
2022-09
0
2.76
2022-10
0
1.61
2022-11
0
2
2022-12
0
2.13
2023-01
0
2.17
2023-02
0
2.13
2023-03
0
2.31
2023-04
0
1.8
2023-05
0
1.88
2023-06
0
1.6
2023-07
0
1.92
2023-08
0
1.36
2023-09
0
2.61
2023-10
0
2.35
2023-11
0
2.27
2023-12
0
1.76
2024-01
0
2.32
2024-02
0
2.08
2024-03
0
3.47
2024-04
0
1.66
2024-05
0
2.79
2024-06
0
3.52
2024-07
0
2.1
2024-08
0
1.71
2024-09
0
2.82
2024-10
0
2.13
2024-11
0
1.64
2024-12
0
1.63
2025-01
0
2.19
2025-02
0
2.51
2025-03
0
2.36
2025-04
0
2.14
2025-05
0
2.66
2025-06
0
2.35
2025-07
0
2.04
2025-08
0
1.95
2025-09
0
2.02
2025-10
0
1.88
2025-11
0
2
2025-12
0
2.55
2026-01
0
2.57
2026-02
0
2.39
2026-03
0
2.66
2026-04
0
1.86
2026-05
0
2.64
2026-06
0
4.23
This device (reports/month)Average device in KWQ, OVE (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.