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.
4 linked reportsInjury 4
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
3.07
2019-02
0
2.7
2019-03
0
3.01
2019-04
0
2.78
2019-05
0
2.19
2019-06
0
1.85
2019-07
0
1.92
2019-08
0
2.22
2019-09
0
2.45
2019-10
0
2.69
2019-11
0
2.22
2019-12
0
2.53
2020-01
0
2.77
2020-02
0
2.58
2020-03
0
3.25
2020-04
0
2.34
2020-05
0
2.36
2020-06
0
2.13
2020-07
0
2.54
2020-08
0
1.98
2020-09
0
2.5
2020-10
0
2.52
2020-11
0
2.35
2020-12
0
2.32
2021-01
0
2.41
2021-02
0
2.02
2021-03
0
2.08
2021-04
0
2.14
2021-05
0
1.99
2021-06
0
2.62
2021-07
0
2.44
2021-08
0
2.41
2021-09
0
2.44
2021-10
0
2.2
2021-11
0
2.22
2021-12
0
2.45
2022-01
0
2.15
2022-02
0
2.24
2022-03
0
2.2
2022-04
0
2.25
2022-05
0
2.11
2022-06
0
2.35
2022-07
0
2.14
2022-08
0
2.24
2022-09
0
2.19
2022-10
0
2.19
2022-11
0
2.32
2022-12
0
2.25
2023-01
0
2.32
2023-02
0
2.21
2023-03
0
2.51
2023-04
0
2.35
2023-05
0
2.32
2023-06
0
2.37
2023-07
0
2.18
2023-08
0
2.2
2023-09
0
2.16
2023-10
0
1.72
2023-11
0
1.68
2023-12
0
1.78
2024-01
0
1.84
2024-02
0
2.09
2024-03
0
2.06
2024-04
0
1.83
2024-05
0
2.19
2024-06
0
2
2024-07
0
1.83
2024-08
0
1.96
2024-09
0
2.29
2024-10
0
1.95
2024-11
0
1.79
2024-12
2
1.61
2025-01
0
1.9
2025-02
0
1.57
2025-03
0
1.81
2025-04
0
1.85
2025-05
0
1.75
2025-06
0
1.85
2025-07
0
1.91
2025-08
0
1.77
2025-09
0
1.87
2025-10
0
1.76
2025-11
0
1.86
2025-12
0
1.89
2026-01
0
2.08
2026-02
0
1.7
2026-03
0
2.03
2026-04
2
1.79
2026-05
0
1.74
2026-06
0
1.76
This device (reports/month)Average device in KRO, KWL, LPH, LWJ (reports/device/month)
Failure-mode summaryAI-generated
4 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.