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.
1 linked reportMalfunction 1
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
2.1
2019-02
0
1.59
2019-03
0
1.67
2019-04
0
2.24
2019-05
0
1.76
2019-06
0
1.82
2019-07
0
2.05
2019-08
0
2.01
2019-09
0
1.76
2019-10
0
1.71
2019-11
0
2
2019-12
0
2.53
2020-01
0
2.55
2020-02
0
2.28
2020-03
0
1.87
2020-04
0
1.91
2020-05
0
1.88
2020-06
0
2.1
2020-07
0
2.65
2020-08
0
2.53
2020-09
0
2.61
2020-10
0
2.23
2020-11
0
2.8
2020-12
0
2.46
2021-01
0
1.87
2021-02
0
2.35
2021-03
0
2.56
2021-04
0
2.69
2021-05
0
2.38
2021-06
0
2.19
2021-07
0
2.27
2021-08
0
2.12
2021-09
1
2.37
2021-10
0
2.07
2021-11
0
2.31
2021-12
0
2.34
2022-01
0
2.95
2022-02
0
2.22
2022-03
0
2.03
2022-04
0
2.06
2022-05
0
2.36
2022-06
0
2.21
2022-07
0
2.18
2022-08
0
2.65
2022-09
0
2.86
2022-10
0
2.93
2022-11
0
3
2022-12
0
5.44
2023-01
0
2.71
2023-02
0
2.86
2023-03
0
3.07
2023-04
0
2.79
2023-05
0
3.3
2023-06
0
2.91
2023-07
0
2.24
2023-08
0
2.21
2023-09
0
2
2023-10
0
2.17
2023-11
0
1.93
2023-12
0
2.66
2024-01
0
2.87
2024-02
0
1.96
2024-03
0
2.4
2024-04
0
2.23
2024-05
0
2.52
2024-06
0
2.66
2024-07
0
2.57
2024-08
0
2.12
2024-09
0
2.21
2024-10
0
2.22
2024-11
0
2.08
2024-12
0
2.71
2025-01
0
2.26
2025-02
0
2.39
2025-03
0
2.12
2025-04
0
2.56
2025-05
0
2.73
2025-06
0
1.95
2025-07
0
2.23
2025-08
0
2.4
2025-09
0
2.09
2025-10
0
2.54
2025-11
0
2.09
2025-12
0
2.67
2026-01
0
2.12
2026-02
0
2.33
2026-03
0
2.66
2026-04
0
2.23
2026-05
0
2.6
2026-06
0
2.36
This device (reports/month)Average device in HTN, HWC (reports/device/month)
Failure-mode summaryAI-generated
1 linked report narrative 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.