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.
11 linked reportsMalfunction 11
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
3.07
2019-02
0
3.8
2019-03
0
3.09
2019-04
0
1.86
2019-05
0
2.02
2019-06
0
1.57
2019-07
0
1.72
2019-08
0
4.08
2019-09
0
2.77
2019-10
0
4.26
2019-11
1
4.47
2019-12
0
4.76
2020-01
4
3.33
2020-02
0
2.1
2020-03
1
3.9
2020-04
0
2.54
2020-05
0
1.55
2020-06
0
1.69
2020-07
0
2.68
2020-08
0
2.92
2020-09
0
2.89
2020-10
0
4.06
2020-11
0
2.7
2020-12
0
2.89
2021-01
0
1.16
2021-02
0
2.22
2021-03
0
1.84
2021-04
0
1.97
2021-05
0
1.66
2021-06
1
2.28
2021-07
0
3.11
2021-08
0
2.31
2021-09
0
4
2021-10
0
2.62
2021-11
0
2
2021-12
0
1.59
2022-01
0
2.18
2022-02
0
1.95
2022-03
0
1.46
2022-04
0
2.44
2022-05
0
2.77
2022-06
0
2.17
2022-07
0
1.77
2022-08
0
2.15
2022-09
0
2.12
2022-10
0
2.46
2022-11
0
2.18
2022-12
0
2.03
2023-01
0
2.73
2023-02
0
2.11
2023-03
0
2.27
2023-04
0
1.65
2023-05
0
2.35
2023-06
0
2.05
2023-07
0
1.75
2023-08
0
2.89
2023-09
0
3.44
2023-10
0
6.93
2023-11
0
6
2023-12
0
7.44
2024-01
0
5.07
2024-02
0
6.33
2024-03
0
6.35
2024-04
0
8.98
2024-05
2
8.71
2024-06
0
6.63
2024-07
0
10.31
2024-08
0
12.34
2024-09
1
17.49
2024-10
0
14.17
2024-11
0
12.6
2024-12
0
9.08
2025-01
0
8.76
2025-02
0
14.62
2025-03
0
13.68
2025-04
0
10.84
2025-05
0
8.45
2025-06
0
9.62
2025-07
0
16.34
2025-08
0
9.21
2025-09
0
10.32
2025-10
0
15.2
2025-11
1
13.17
2025-12
0
12.27
2026-01
0
9.72
2026-02
0
9.3
2026-03
0
11.82
2026-04
0
11.74
2026-05
0
12.65
2026-06
0
13.23
This device (reports/month)Average device in ETN, GWF (reports/device/month)
Failure-mode summaryAI-generated
11 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.