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
1.86
2019-02
0
2.54
2019-03
0
2.33
2019-04
0
2.21
2019-05
0
2.65
2019-06
0
2.05
2019-07
0
2.2
2019-08
0
2.08
2019-09
0
2.14
2019-10
0
3.02
2019-11
0
3.05
2019-12
0
2.56
2020-01
0
2.42
2020-02
0
2.92
2020-03
0
2.77
2020-04
0
3.61
2020-05
0
1.73
2020-06
0
2.58
2020-07
0
2.6
2020-08
0
2.13
2020-09
0
2.59
2020-10
0
3.4
2020-11
0
3.46
2020-12
0
2.76
2021-01
0
2.81
2021-02
0
3.11
2021-03
0
2.66
2021-04
0
2.78
2021-05
0
2.84
2021-06
0
2.63
2021-07
0
2.57
2021-08
0
2.06
2021-09
0
2.39
2021-10
0
1.95
2021-11
0
2.38
2021-12
0
2.24
2022-01
0
1.87
2022-02
0
2.37
2022-03
0
2.55
2022-04
0
2.05
2022-05
0
2.51
2022-06
0
2.82
2022-07
0
2.91
2022-08
0
2.14
2022-09
0
1.92
2022-10
0
3.17
2022-11
0
2.2
2022-12
0
2.73
2023-01
0
2.58
2023-02
0
2.51
2023-03
0
2.66
2023-04
0
2.3
2023-05
0
2.2
2023-06
0
1.99
2023-07
0
2.17
2023-08
0
2.01
2023-09
0
2.25
2023-10
0
2.24
2023-11
0
4.1
2023-12
0
2.56
2024-01
0
2.42
2024-02
0
2.93
2024-03
0
2.44
2024-04
0
2.27
2024-05
0
3.01
2024-06
0
2.78
2024-07
0
2.6
2024-08
0
2.83
2024-09
0
2.8
2024-10
0
3.49
2024-11
0
3.34
2024-12
0
2.96
2025-01
0
5.02
2025-02
0
3.15
2025-03
0
2.7
2025-04
0
2.72
2025-05
0
2.96
2025-06
0
2.86
2025-07
0
2.87
2025-08
0
3.1
2025-09
0
2.75
2025-10
0
3.13
2025-11
0
3.42
2025-12
0
3.28
2026-01
0
3.06
2026-02
0
3.11
2026-03
0
2.63
2026-04
0
2.62
2026-05
0
3
2026-06
1
2.81
This device (reports/month)Average device in HWT, OLO (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.