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.
9 linked reportsInjury 7Malfunction 2
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
2.71
2019-02
0
3.5
2019-03
0
2.77
2019-04
0
1.75
2019-05
0
2.27
2019-06
0
1.56
2019-07
0
1.53
2019-08
0
3.77
2019-09
0
2.69
2019-10
0
3.56
2019-11
0
3.74
2019-12
0
4.11
2020-01
0
2.65
2020-02
0
1.91
2020-03
0
3.32
2020-04
0
2.39
2020-05
0
1.42
2020-06
0
1.63
2020-07
0
2.13
2020-08
0
2.69
2020-09
0
2.65
2020-10
0
3.66
2020-11
0
2.63
2020-12
0
2.47
2021-01
0
1.14
2021-02
0
2
2021-03
0
1.65
2021-04
0
1.83
2021-05
2
1.55
2021-06
0
2.11
2021-07
1
2.47
2021-08
4
2.24
2021-09
0
3.6
2021-10
0
2.62
2021-11
0
1.8
2021-12
0
1.48
2022-01
0
1.95
2022-02
0
1.77
2022-03
0
1.37
2022-04
0
2.39
2022-05
0
2.74
2022-06
0
2.11
2022-07
0
1.73
2022-08
0
2.13
2022-09
0
2.09
2022-10
0
2.35
2022-11
0
2.07
2022-12
0
1.95
2023-01
0
2.56
2023-02
0
2.05
2023-03
0
2.46
2023-04
0
1.8
2023-05
0
2.3
2023-06
0
2.31
2023-07
0
1.73
2023-08
0
2.73
2023-09
0
3.16
2023-10
0
6.92
2023-11
0
5.49
2023-12
0
6.91
2024-01
0
5.17
2024-02
0
6.65
2024-03
0
5.45
2024-04
0
7.76
2024-05
0
7.8
2024-06
0
5.96
2024-07
0
9.17
2024-08
0
12.11
2024-09
0
15.27
2024-10
0
13.04
2024-11
0
11.41
2024-12
0
8.76
2025-01
0
8.61
2025-02
0
16.3
2025-03
0
11.36
2025-04
0
10.57
2025-05
0
8.09
2025-06
0
8.79
2025-07
0
16.3
2025-08
0
8.26
2025-09
0
9.59
2025-10
0
14.94
2025-11
0
12.39
2025-12
0
11.57
2026-01
0
9.18
2026-02
0
8
2026-03
0
10.71
2026-04
2
10.32
2026-05
0
10.58
2026-06
0
12.25
This device (reports/month)Average device in ETN, PDQ (reports/device/month)
Failure-mode summaryAI-generated
9 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.