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.
2 linked reportsMalfunction 2
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
1.89
2019-03
0
1.97
2019-04
0
1.97
2019-05
0
2.22
2019-06
0
2.44
2019-07
0
1.64
2019-08
0
2.65
2019-09
0
1.76
2019-10
0
1.85
2019-11
0
2.16
2019-12
0
1.65
2020-01
0
2.33
2020-02
0
2.3
2020-03
0
2.21
2020-04
0
1.54
2020-05
0
2.2
2020-06
0
1.89
2020-07
0
1.75
2020-08
0
1.88
2020-09
0
2.36
2020-10
0
2.46
2020-11
0
2.3
2020-12
0
2.05
2021-01
0
2.17
2021-02
0
1.84
2021-03
0
2.32
2021-04
0
2.17
2021-05
0
2
2021-06
0
1.8
2021-07
0
7.23
2021-08
0
1.92
2021-09
0
1.69
2021-10
0
2.42
2021-11
0
2.12
2021-12
0
2.14
2022-01
0
2.07
2022-02
0
1.9
2022-03
0
1.8
2022-04
0
1.92
2022-05
0
1.73
2022-06
0
1.96
2022-07
0
3.53
2022-08
0
1.9
2022-09
0
2.71
2022-10
0
1.42
2022-11
0
1.71
2022-12
0
1.98
2023-01
0
1.63
2023-02
0
1.75
2023-03
0
1.84
2023-04
0
2
2023-05
0
1.56
2023-06
0
1.71
2023-07
0
1.83
2023-08
0
1.44
2023-09
0
2.71
2023-10
0
2.6
2023-11
0
2.44
2023-12
0
1.68
2024-01
0
2.44
2024-02
0
2.14
2024-03
0
3.78
2024-04
0
1.76
2024-05
0
3.39
2024-06
0
1.98
2024-07
0
1.83
2024-08
0
1.92
2024-09
0
2.36
2024-10
0
2.09
2024-11
0
2.09
2024-12
0
1.75
2025-01
0
2.25
2025-02
0
2.44
2025-03
0
2.31
2025-04
0
2.32
2025-05
0
2.26
2025-06
0
2.14
2025-07
0
2.2
2025-08
0
1.9
2025-09
0
1.9
2025-10
0
1.98
2025-11
0
1.94
2025-12
2
2.22
2026-01
0
2.44
2026-02
0
2.41
2026-03
0
2.47
2026-04
0
1.82
2026-05
0
1.99
2026-06
0
4.59
This device (reports/month)Average device in KWP, MNI (reports/device/month)
Failure-mode summaryAI-generated
2 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.