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.
7 linked reportsDeath 6Malfunction 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
16.72
2019-02
0
19
2019-03
0
11.14
2019-04
0
12.86
2019-05
0
13.64
2019-06
0
10.23
2019-07
0
18
2019-08
0
12.69
2019-09
0
13.4
2019-10
0
15.25
2019-11
0
16.67
2019-12
0
19.22
2020-01
0
15.69
2020-02
0
18.64
2020-03
0
14.15
2020-04
0
14.79
2020-05
0
10
2020-06
0
10.08
2020-07
0
14.6
2020-08
1
12.5
2020-09
0
13.67
2020-10
0
19.68
2020-11
0
15.5
2020-12
0
22.05
2021-01
0
18.68
2021-02
3
19.35
2021-03
0
17.17
2021-04
0
15.61
2021-05
0
13
2021-06
0
20.28
2021-07
0
14
2021-08
0
18.74
2021-09
0
15.69
2021-10
0
22.28
2021-11
0
22
2021-12
0
14.33
2022-01
0
10.9
2022-02
0
13.37
2022-03
0
28.63
2022-04
0
13.43
2022-05
1
13.81
2022-06
0
17.38
2022-07
0
11.36
2022-08
1
14.48
2022-09
0
26
2022-10
0
27.03
2022-11
0
17.36
2022-12
0
22.09
2023-01
0
18.39
2023-02
0
19.58
2023-03
0
21.68
2023-04
0
18.29
2023-05
0
15.39
2023-06
0
12.4
2023-07
0
13.23
2023-08
0
21.18
2023-09
0
19.14
2023-10
0
17.39
2023-11
0
22.07
2023-12
0
21.39
2024-01
1
36.09
2024-02
0
25.91
2024-03
0
22.25
2024-04
0
19.35
2024-05
0
23.16
2024-06
0
21.88
2024-07
0
27.58
2024-08
0
23.72
2024-09
0
35.31
2024-10
0
47.65
2024-11
0
43.38
2024-12
0
28.05
2025-01
0
37.22
2025-02
0
30.5
2025-03
0
41.11
2025-04
0
34.49
2025-05
0
38.1
2025-06
0
27.49
2025-07
0
26.1
2025-08
0
23.76
2025-09
0
26.07
2025-10
0
22.55
2025-11
0
27.57
2025-12
0
26.72
2026-01
0
19.33
2026-02
0
24
2026-03
0
32.31
2026-04
0
50.65
2026-05
0
28.68
2026-06
0
26.9
This device (reports/month)Average device in NOU (reports/device/month)
Failure-mode summaryAI-generated
7 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.