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
2.8
2019-02
0
1.29
2019-03
0
1.2
2019-04
0
1.71
2019-05
0
1.91
2019-06
0
1.5
2019-07
0
1.8
2019-08
0
2.33
2019-09
0
1.85
2019-10
0
2.2
2019-11
0
2.44
2019-12
0
3.29
2020-01
0
1.8
2020-02
0
2
2020-03
0
3.2
2020-04
0
1.83
2020-05
0
1.5
2020-06
0
3
2020-07
0
2.17
2020-08
0
4.4
2020-09
0
19.25
2020-10
0
19.67
2020-11
0
60.38
2020-12
0
186
2021-01
0
111
2021-02
0
13.75
2021-03
0
9.56
2021-04
0
6.54
2021-05
0
9.43
2021-06
0
17.33
2021-07
0
16.89
2021-08
0
11
2021-09
0
9.8
2021-10
0
15.37
2021-11
0
15.92
2021-12
0
38.83
2022-01
0
31
2022-02
0
23.38
2022-03
0
38.75
2022-04
0
21.5
2022-05
0
20.89
2022-06
0
17.8
2022-07
0
20.5
2022-08
0
13.74
2022-09
0
16
2022-10
0
14.92
2022-11
0
18
2022-12
0
29.38
2023-01
0
14.7
2023-02
0
22
2023-03
0
22.25
2023-04
0
28.75
2023-05
0
25.5
2023-06
0
20.89
2023-07
0
15.09
2023-08
0
19.29
2023-09
0
12.58
2023-10
0
16
2023-11
0
13.33
2023-12
0
6.18
2024-01
0
9.29
2024-02
0
20.18
2024-03
0
17.58
2024-04
0
9.14
2024-05
0
7
2024-06
0
9.14
2024-07
0
10.54
2024-08
0
12.54
2024-09
0
16.7
2024-10
0
11.76
2024-11
0
8.86
2024-12
0
17.89
2025-01
0
8.11
2025-02
0
9.6
2025-03
0
11.11
2025-04
0
14.31
2025-05
0
11.39
2025-06
0
10.14
2025-07
0
23.13
2025-08
0
10
2025-09
0
7.7
2025-10
0
12.53
2025-11
0
11
2025-12
0
16.29
2026-01
0
11.4
2026-02
0
16.38
2026-03
1
10.64
2026-04
0
14.65
2026-05
0
26
2026-06
0
49.6
This device (reports/month)Average device in CCK (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.