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
10.5
2019-02
0
11.13
2019-03
0
8.57
2019-04
0
9.4
2019-05
0
8.47
2019-06
0
7.73
2019-07
0
8.03
2019-08
0
9.07
2019-09
0
12
2019-10
0
9.49
2019-11
0
8.85
2019-12
0
10.21
2020-01
0
9.41
2020-02
0
8.76
2020-03
0
8.97
2020-04
0
13.14
2020-05
0
9.03
2020-06
0
8.36
2020-07
0
8.15
2020-08
0
8.91
2020-09
0
10.35
2020-10
0
10.15
2020-11
0
11.16
2020-12
0
10.8
2021-01
0
10.02
2021-02
0
10.55
2021-03
0
14.58
2021-04
0
8.9
2021-05
0
7.47
2021-06
0
9.93
2021-07
0
8.43
2021-08
0
7.77
2021-09
0
7.44
2021-10
0
10.18
2021-11
0
10.54
2021-12
0
7.71
2022-01
0
7.26
2022-02
0
8.28
2022-03
0
11.32
2022-04
0
11.07
2022-05
0
15.27
2022-06
0
10.68
2022-07
0
7.27
2022-08
0
9.14
2022-09
0
12.08
2022-10
0
16.46
2022-11
0
9.11
2022-12
0
12.31
2023-01
0
10.07
2023-02
0
17.6
2023-03
0
19.41
2023-04
0
21.93
2023-05
0
21.78
2023-06
0
14.76
2023-07
0
27.83
2023-08
0
32.21
2023-09
0
32.73
2023-10
0
21.29
2023-11
0
31.3
2023-12
0
28.87
2024-01
0
26.92
2024-02
0
23.95
2024-03
0
30.02
2024-04
0
16.76
2024-05
0
18.2
2024-06
0
15.54
2024-07
0
26.88
2024-08
0
24.81
2024-09
0
30.13
2024-10
0
36.26
2024-11
0
26.81
2024-12
0
22.65
2025-01
0
28.25
2025-02
0
22
2025-03
0
27.79
2025-04
0
17.38
2025-05
0
14.64
2025-06
0
10.52
2025-07
0
10.23
2025-08
0
8.61
2025-09
0
9.3
2025-10
0
14.12
2025-11
0
8.46
2025-12
0
11.1
2026-01
0
11.34
2026-02
3
10.34
2026-03
0
11.79
2026-04
0
31.1
2026-05
0
15.68
2026-06
0
13.5
This device (reports/month)Average device in DQA (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.