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.
3 linked reportsMalfunction 3
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
4.2
2019-02
0
3.58
2019-03
0
6.27
2019-04
0
5.47
2019-05
3
3.92
2019-06
0
4.13
2019-07
0
4.17
2019-08
0
5.32
2019-09
0
4.17
2019-10
0
4.24
2019-11
0
5.24
2019-12
0
5.06
2020-01
0
4.4
2020-02
0
3.92
2020-03
0
4.79
2020-04
0
4.51
2020-05
0
2.98
2020-06
0
5.68
2020-07
0
5.4
2020-08
0
4.57
2020-09
0
4.43
2020-10
0
5.14
2020-11
0
4.88
2020-12
0
5.08
2021-01
0
4.86
2021-02
0
5.1
2021-03
0
5.73
2021-04
0
4.56
2021-05
0
4.56
2021-06
0
5.43
2021-07
0
4.49
2021-08
0
4.87
2021-09
0
3.93
2021-10
0
3.19
2021-11
0
4.08
2021-12
0
3.67
2022-01
0
3.52
2022-02
0
3.15
2022-03
0
3.37
2022-04
0
3.75
2022-05
0
2.97
2022-06
0
4.16
2022-07
0
4.17
2022-08
0
4.26
2022-09
0
3.72
2022-10
0
4.13
2022-11
0
4.3
2022-12
0
4.24
2023-01
0
3.42
2023-02
0
3.95
2023-03
0
4.6
2023-04
0
4
2023-05
0
5.03
2023-06
0
3.99
2023-07
0
4.33
2023-08
0
3.73
2023-09
0
3.85
2023-10
0
3.6
2023-11
0
3.86
2023-12
0
3.34
2024-01
0
4.05
2024-02
0
4.64
2024-03
0
4.32
2024-04
0
4.26
2024-05
0
3.3
2024-06
0
3.43
2024-07
0
3.6
2024-08
0
3.6
2024-09
0
4.95
2024-10
0
4.01
2024-11
0
3.64
2024-12
0
3.46
2025-01
0
2.95
2025-02
0
6.82
2025-03
0
4.95
2025-04
0
3.08
2025-05
0
4.42
2025-06
0
3.56
2025-07
0
3.98
2025-08
0
3.5
2025-09
0
3.1
2025-10
0
3.8
2025-11
0
3.27
2025-12
0
3.46
2026-01
0
2.62
2026-02
0
3.38
2026-03
0
3.6
2026-04
0
5.25
2026-05
0
3.94
2026-06
0
4.1
This device (reports/month)Average device in ERL (reports/device/month)
Failure-mode summaryAI-generated
3 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.