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.
4 linked reportsMalfunction 4
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
1.93
2019-02
0
1.67
2019-03
0
1.79
2019-04
0
1.67
2019-05
0
1.8
2019-06
0
1.84
2019-07
0
1.69
2019-08
0
2.17
2019-09
0
1.7
2019-10
0
2.03
2019-11
1
1.95
2019-12
0
1.63
2020-01
0
2.39
2020-02
0
1.97
2020-03
1
1.79
2020-04
0
1.61
2020-05
0
1.96
2020-06
0
2.12
2020-07
0
2.11
2020-08
0
1.77
2020-09
0
2.43
2020-10
0
2.34
2020-11
0
2.58
2020-12
0
1.93
2021-01
0
1.78
2021-02
0
1.82
2021-03
0
2.16
2021-04
0
1.85
2021-05
0
1.92
2021-06
1
2.16
2021-07
0
2.12
2021-08
0
2.29
2021-09
0
1.8
2021-10
0
2.54
2021-11
0
2.04
2021-12
0
2.6
2022-01
0
2.7
2022-02
0
2.4
2022-03
0
1.82
2022-04
0
1.76
2022-05
1
2.12
2022-06
0
1.98
2022-07
0
2.93
2022-08
0
2.19
2022-09
0
2.5
2022-10
0
1.71
2022-11
0
1.99
2022-12
0
1.91
2023-01
0
2.14
2023-02
0
2.05
2023-03
0
2.02
2023-04
0
1.82
2023-05
0
1.95
2023-06
0
1.61
2023-07
0
1.97
2023-08
0
1.53
2023-09
0
2.26
2023-10
0
2.1
2023-11
0
5.42
2023-12
0
2.78
2024-01
0
2.19
2024-02
0
2.11
2024-03
0
3.01
2024-04
0
1.6
2024-05
0
2.63
2024-06
0
2.79
2024-07
0
2.08
2024-08
0
1.93
2024-09
0
2.44
2024-10
0
2.16
2024-11
0
1.72
2024-12
0
1.73
2025-01
0
2.05
2025-02
0
2.11
2025-03
0
1.99
2025-04
0
1.86
2025-05
0
2.26
2025-06
0
2.15
2025-07
0
1.99
2025-08
0
1.81
2025-09
0
1.85
2025-10
0
1.83
2025-11
0
1.95
2025-12
0
2.26
2026-01
0
2.3
2026-02
0
2
2026-03
0
2.74
2026-04
0
1.8
2026-05
0
1.96
2026-06
0
3.14
This device (reports/month)Average device in KWQ, MAX, OVD (reports/device/month)
Failure-mode summaryAI-generated
4 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.