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.
44 linked reportsMalfunction 42Injury 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
2019-02
0
3.67
2019-03
0
1.67
2019-04
0
2
2019-05
0
2.11
2019-06
0
1.29
2019-07
0
2.8
2019-08
0
1.78
2019-09
0
1.13
2019-10
0
1.5
2019-11
0
1.2
2019-12
0
2
2020-01
0
1
2020-02
0
2.5
2020-03
1
3.14
2020-04
0
6.2
2020-05
0
6.8
2020-06
0
6.63
2020-07
0
10.57
2020-08
0
8.78
2020-09
0
20.25
2020-10
0
11.43
2020-11
1
17
2020-12
0
16
2021-01
2
8.89
2021-02
0
16.5
2021-03
0
40.2
2021-04
0
21.3
2021-05
0
15.25
2021-06
0
9.83
2021-07
0
20.57
2021-08
0
15.5
2021-09
0
10.67
2021-10
0
7.82
2021-11
0
14.17
2021-12
0
16.25
2022-01
0
8.09
2022-02
1
15.25
2022-03
1
9.5
2022-04
0
9.45
2022-05
0
18.33
2022-06
0
21.83
2022-07
0
9.75
2022-08
0
9.86
2022-09
0
8.7
2022-10
2
8.67
2022-11
0
5.44
2022-12
0
7.58
2023-01
0
8.12
2023-02
0
13
2023-03
0
9.13
2023-04
0
5.61
2023-05
0
7.5
2023-06
0
6.74
2023-07
0
11.43
2023-08
0
8
2023-09
0
11.67
2023-10
0
9.53
2023-11
0
10.6
2023-12
0
12.38
2024-01
0
20.36
2024-02
0
10.35
2024-03
1
10.85
2024-04
0
10.73
2024-05
0
8.69
2024-06
0
11.31
2024-07
2
7.59
2024-08
0
10.64
2024-09
0
11.29
2024-10
1
11.72
2024-11
0
5.7
2024-12
4
3
2025-01
1
5.44
2025-02
4
3.73
2025-03
0
5.86
2025-04
0
4.13
2025-05
1
4.36
2025-06
0
5.88
2025-07
0
4.36
2025-08
0
7
2025-09
0
9.29
2025-10
3
8.62
2025-11
4
13.82
2025-12
1
23.25
2026-01
0
25.15
2026-02
2
17.9
2026-03
8
17.63
2026-04
0
39.14
2026-05
4
42.36
2026-06
0
43
This device (reports/month)Average device in FEB (reports/device/month)
Failure-mode summaryAI-generated
40 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.