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
2019-02
0
1.57
2019-03
0
1.71
2019-04
0
2.26
2019-05
0
1.69
2019-06
0
1.72
2019-07
0
1.93
2019-08
0
1.83
2019-09
0
1.69
2019-10
0
1.58
2019-11
0
1.82
2019-12
0
2.19
2020-01
0
2.33
2020-02
0
1.48
2020-03
0
1.74
2020-04
0
1.84
2020-05
0
1.71
2020-06
0
2
2020-07
0
2.27
2020-08
0
2.39
2020-09
0
2.56
2020-10
0
2.12
2020-11
0
2.53
2020-12
0
2.37
2021-01
0
1.8
2021-02
0
2.19
2021-03
0
2.41
2021-04
0
2.72
2021-05
0
2.55
2021-06
0
2.11
2021-07
0
2.22
2021-08
0
1.94
2021-09
0
2.18
2021-10
0
1.98
2021-11
0
2.26
2021-12
0
2.23
2022-01
0
2.83
2022-02
0
2.22
2022-03
0
1.91
2022-04
0
2.01
2022-05
0
2.31
2022-06
0
2.27
2022-07
0
2.2
2022-08
0
2.28
2022-09
0
2.68
2022-10
0
3
2022-11
0
3.02
2022-12
0
4.35
2023-01
0
2.66
2023-02
0
2.69
2023-03
0
2.95
2023-04
0
2.85
2023-05
0
3.55
2023-06
0
2.89
2023-07
0
2.25
2023-08
0
2.11
2023-09
0
2.06
2023-10
0
2.2
2023-11
0
1.89
2023-12
0
2.37
2024-01
0
2.45
2024-02
0
1.8
2024-03
0
2.08
2024-04
0
2.1
2024-05
0
2.11
2024-06
0
2.25
2024-07
0
2.31
2024-08
0
2.14
2024-09
0
1.91
2024-10
0
2.22
2024-11
0
1.89
2024-12
0
2.84
2025-01
0
1.97
2025-02
0
2.02
2025-03
0
2.28
2025-04
0
2.28
2025-05
0
2.31
2025-06
0
1.84
2025-07
0
2.1
2025-08
0
2.19
2025-09
0
1.94
2025-10
0
2.32
2025-11
0
1.98
2025-12
0
2.56
2026-01
0
1.9
2026-02
1
2.16
2026-03
0
2.69
2026-04
0
2.17
2026-05
0
2.45
2026-06
0
2.13
This device (reports/month)Average device in HRS, HWC, KTT (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.