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.
1 linked reportMalfunction 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
5.06
2019-02
0
4.07
2019-03
0
4.63
2019-04
0
4.62
2019-05
0
4.69
2019-06
0
4.3
2019-07
0
5
2019-08
0
6.17
2019-09
0
5.48
2019-10
0
5.14
2019-11
0
7.13
2019-12
0
6.59
2020-01
0
6.93
2020-02
0
5.15
2020-03
0
6.97
2020-04
0
8.85
2020-05
0
7.63
2020-06
0
6.74
2020-07
0
6.71
2020-08
0
6.78
2020-09
0
6.02
2020-10
0
7.39
2020-11
0
8.82
2020-12
0
9.67
2021-01
0
9.29
2021-02
0
9.91
2021-03
0
8.62
2021-04
0
8.69
2021-05
0
7.86
2021-06
1
6.39
2021-07
0
8.38
2021-08
0
6.93
2021-09
0
7.23
2021-10
0
7.79
2021-11
0
8.31
2021-12
0
8.71
2022-01
0
6.9
2022-02
0
7.45
2022-03
0
8.41
2022-04
0
6.2
2022-05
0
7.71
2022-06
0
6.51
2022-07
0
6.39
2022-08
0
9
2022-09
0
7.01
2022-10
0
8.23
2022-11
0
9.39
2022-12
0
8.84
2023-01
0
9.38
2023-02
0
9.48
2023-03
0
11.29
2023-04
0
11.77
2023-05
0
11.2
2023-06
0
12.06
2023-07
0
13.11
2023-08
0
11.98
2023-09
0
9.29
2023-10
0
12.14
2023-11
0
6.69
2023-12
0
10.84
2024-01
0
7.89
2024-02
0
11.03
2024-03
0
19.86
2024-04
0
37.72
2024-05
0
46.73
2024-06
0
38.81
2024-07
0
33.83
2024-08
0
16.63
2024-09
0
16.46
2024-10
0
11.54
2024-11
0
10.1
2024-12
0
7.89
2025-01
0
7.58
2025-02
0
6.11
2025-03
0
7.3
2025-04
0
7.87
2025-05
0
8.57
2025-06
0
8.17
2025-07
0
5.91
2025-08
0
7.2
2025-09
0
5.11
2025-10
0
5.73
2025-11
0
9.89
2025-12
0
6.73
2026-01
0
7.79
2026-02
0
10.15
2026-03
0
7.25
2026-04
0
8.01
2026-05
0
8.22
2026-06
0
8.9
This device (reports/month)Average device in GAT, NEW (reports/device/month)
Failure-mode summaryAI-generated
1 linked report narrative 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.