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 reportsMalfunction 8Injury 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
1
2019-02
0
1
2019-04
0
1
2019-05
0
2.25
2019-06
0
1
2019-07
0
1.33
2019-08
0
2.8
2019-09
0
2
2019-10
0
1.33
2019-11
0
1.5
2019-12
0
1.4
2020-01
0
1.5
2020-02
0
2.6
2020-04
0
2.71
2020-05
0
2.25
2020-06
0
3.42
2020-07
0
3.59
2020-08
0
5
2020-09
0
4.1
2020-10
0
8.22
2020-11
0
8
2020-12
0
5.17
2021-01
0
6.5
2021-02
0
5.62
2021-03
0
7.92
2021-04
0
8.33
2021-05
0
6.07
2021-06
0
4.73
2021-07
0
5.21
2021-08
0
7
2021-09
0
6.13
2021-10
0
5.56
2021-11
0
6.69
2021-12
0
6.47
2022-01
0
8.16
2022-02
0
10.65
2022-03
0
13.13
2022-04
0
16.29
2022-05
0
12.16
2022-06
0
13.61
2022-07
0
13.61
2022-08
0
15.76
2022-09
0
12.82
2022-10
0
12
2022-11
0
11.35
2022-12
0
12.59
2023-01
0
11.14
2023-02
0
8.04
2023-03
0
12
2023-04
0
12
2023-05
0
9.04
2023-06
0
10.86
2023-07
0
8.62
2023-08
0
10.58
2023-09
0
11.52
2023-10
0
10.88
2023-11
0
11.48
2023-12
0
8.04
2024-01
0
7.22
2024-02
0
9.57
2024-03
0
9.24
2024-04
0
7.37
2024-05
0
6.67
2024-06
0
8.72
2024-07
0
8.96
2024-08
2
9
2024-09
0
7.93
2024-10
0
9.89
2024-11
0
5.89
2024-12
0
5
2025-01
0
3.11
2025-02
0
2.45
2025-03
0
4.33
2025-04
0
3.9
2025-05
0
3.63
2025-06
0
3.86
2025-07
0
4.2
2025-08
0
4.83
2025-09
0
3.55
2025-10
0
4.84
2025-11
0
3.58
2025-12
2
6.72
2026-01
2
8.54
2026-02
1
5.85
2026-03
0
5.25
2026-04
2
7.23
2026-05
0
8.17
2026-06
0
6.81
This device (reports/month)Average device in FGB (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.