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.
10 linked reportsInjury 10
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
1.41
2019-02
0
1.33
2019-03
0
2.41
2019-04
0
2.95
2019-05
4
3.31
2019-06
0
1.41
2019-07
0
1.76
2019-08
0
2
2019-09
0
2.17
2019-10
0
2.53
2019-11
0
1.72
2019-12
0
2.35
2020-01
0
2.54
2020-02
0
1.83
2020-03
0
2.06
2020-04
0
2.13
2020-05
0
2.31
2020-06
0
2
2020-07
0
2.17
2020-08
0
2.21
2020-09
0
2.06
2020-10
0
2.22
2020-11
0
1.71
2020-12
0
1.9
2021-01
3
2.13
2021-02
0
1.25
2021-03
0
2
2021-04
0
3.33
2021-05
0
4.09
2021-06
0
1.93
2021-07
0
1.33
2021-08
0
3.31
2021-09
0
1.58
2021-10
0
2.12
2021-11
0
2
2021-12
0
3.93
2022-01
0
2
2022-02
0
2.67
2022-03
0
3.5
2022-04
0
2.36
2022-05
0
1.77
2022-06
0
2.5
2022-07
0
2.16
2022-08
0
2.15
2022-09
0
1.5
2022-10
0
6.64
2022-11
0
2.27
2022-12
0
3.37
2023-01
0
2.67
2023-02
0
3.26
2023-03
0
2.67
2023-04
0
1.5
2023-05
0
2.88
2023-06
0
4.15
2023-07
0
3.81
2023-08
0
3.07
2023-09
0
2.58
2023-10
0
1.44
2023-11
0
2.68
2023-12
0
2.05
2024-01
0
2.89
2024-02
0
2.67
2024-03
0
2.23
2024-04
0
2.61
2024-05
0
2.29
2024-06
0
1.83
2024-07
0
1.55
2024-08
0
1.6
2024-09
0
2.07
2024-10
0
2.29
2024-11
0
2.75
2024-12
0
1.7
2025-01
0
1.5
2025-02
0
1.38
2025-03
0
2
2025-04
0
1.9
2025-05
0
2.27
2025-06
0
2
2025-07
0
4.1
2025-08
0
2.57
2025-09
0
1.69
2025-10
0
1.95
2025-11
0
1.53
2025-12
0
4.38
2026-01
0
1.57
2026-02
0
2.45
2026-03
0
1.11
2026-04
3
3.09
2026-05
0
2.1
2026-06
0
3.56
This device (reports/month)Average device in JEY (reports/device/month)
Failure-mode summaryAI-generated
10 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.