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.
13 linked reportsInjury 13
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
1.8
2019-02
0
1.85
2019-03
0
1.75
2019-04
0
1.87
2019-05
0
2.1
2019-06
0
1.89
2019-07
0
1.69
2019-08
0
2.18
2019-09
0
1.68
2019-10
0
1.87
2019-11
1
1.67
2019-12
0
1.75
2020-01
1
1.9
2020-02
0
2.05
2020-03
0
2.16
2020-04
1
1.76
2020-05
0
1.66
2020-06
0
1.91
2020-07
0
2.24
2020-08
0
1.75
2020-09
0
1.94
2020-10
0
2.19
2020-11
0
1.91
2020-12
0
1.87
2021-01
0
2.19
2021-02
1
1.95
2021-03
0
2.12
2021-04
0
2.03
2021-05
0
1.96
2021-06
0
1.9
2021-07
0
2.04
2021-08
0
2.18
2021-09
0
1.92
2021-10
0
2.14
2021-11
0
2.11
2021-12
0
2.56
2022-01
1
2.57
2022-02
0
2.3
2022-03
1
2.4
2022-04
0
2.43
2022-05
0
2.08
2022-06
0
2.19
2022-07
0
2.16
2022-08
0
2.21
2022-09
1
2.02
2022-10
0
2.07
2022-11
0
2.13
2022-12
0
2.05
2023-01
0
1.83
2023-02
0
1.98
2023-03
0
1.97
2023-04
0
2.18
2023-05
0
2.06
2023-06
0
2.24
2023-07
0
2.05
2023-08
0
1.7
2023-09
0
1.56
2023-10
0
1.61
2023-11
3
1.69
2023-12
0
1.44
2024-01
0
1.84
2024-02
0
1.87
2024-03
0
1.69
2024-04
1
1.83
2024-05
0
1.69
2024-06
1
1.84
2024-07
0
1.62
2024-08
0
1.7
2024-09
0
1.68
2024-10
0
1.69
2024-11
0
1.59
2024-12
0
1.62
2025-01
0
1.73
2025-02
0
1.62
2025-03
0
1.89
2025-04
0
1.69
2025-05
1
1.81
2025-06
0
1.92
2025-07
0
1.77
2025-08
0
1.6
2025-09
0
1.49
2025-10
0
1.65
2025-11
0
1.73
2025-12
0
2.21
2026-01
0
1.93
2026-02
0
1.8
2026-03
0
1.78
2026-04
0
1.72
2026-05
0
1.75
2026-06
0
1.76
This device (reports/month)Average device in KWS, PAO, PHX (reports/device/month)
Failure-mode summaryAI-generated
13 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.