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.
12 linked reportsInjury 12
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
1.66
2019-02
2
1.6
2019-03
0
1.69
2019-04
2
1.53
2019-05
0
1.76
2019-06
0
1.88
2019-07
0
1.42
2019-08
0
1.97
2019-09
0
1.5
2019-10
0
1.8
2019-11
0
1.56
2019-12
0
1.72
2020-01
0
1.81
2020-02
0
2.09
2020-03
0
1.74
2020-04
0
1.67
2020-05
0
1.44
2020-06
0
1.77
2020-07
0
1.93
2020-08
0
1.62
2020-09
0
1.89
2020-10
2
2.09
2020-11
0
1.87
2020-12
0
1.82
2021-01
0
1.94
2021-02
2
1.78
2021-03
0
1.94
2021-04
0
1.81
2021-05
0
1.69
2021-06
0
1.63
2021-07
0
1.86
2021-08
0
2.02
2021-09
0
1.61
2021-10
0
1.69
2021-11
0
1.95
2021-12
0
1.95
2022-01
0
2.01
2022-02
2
2
2022-03
0
1.69
2022-04
0
2.01
2022-05
0
1.82
2022-06
0
1.96
2022-07
0
2
2022-08
0
1.94
2022-09
0
1.84
2022-10
0
1.82
2022-11
0
1.99
2022-12
0
1.78
2023-01
0
1.71
2023-02
0
1.84
2023-03
0
1.83
2023-04
0
1.9
2023-05
0
1.92
2023-06
0
2.15
2023-07
0
1.98
2023-08
0
1.59
2023-09
0
1.48
2023-10
0
1.53
2023-11
0
1.6
2023-12
0
1.39
2024-01
1
1.89
2024-02
0
1.74
2024-03
0
1.63
2024-04
0
1.72
2024-05
0
1.67
2024-06
0
1.81
2024-07
0
1.59
2024-08
0
1.65
2024-09
0
1.62
2024-10
0
1.56
2024-11
0
1.52
2024-12
0
1.56
2025-01
0
1.7
2025-02
0
1.51
2025-03
0
1.78
2025-04
0
1.58
2025-05
0
1.74
2025-06
1
1.8
2025-07
0
1.68
2025-08
0
1.52
2025-09
0
1.46
2025-10
0
1.57
2025-11
0
1.69
2025-12
0
2.17
2026-01
0
1.88
2026-02
0
1.72
2026-03
0
1.72
2026-04
0
1.68
2026-05
0
1.68
2026-06
0
1.65
This device (reports/month)Average device in KWS, PAO (reports/device/month)
Failure-mode summaryAI-generated
12 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.