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.
2 linked reportsMalfunction 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
1.33
2019-02
0
1.6
2019-03
0
8.8
2019-04
0
2.5
2019-05
0
5.43
2019-06
0
3.5
2019-07
0
7
2019-08
0
3.33
2019-09
0
6.5
2019-10
0
4.38
2019-11
0
5
2019-12
0
3
2020-01
0
26.25
2020-02
0
9.5
2020-03
0
6.8
2020-04
0
2.57
2020-05
0
5.67
2020-06
0
3.5
2020-07
0
5.11
2020-08
0
5
2020-09
0
8
2020-10
0
3.13
2020-11
0
7.29
2020-12
0
9.67
2021-01
0
6.2
2021-02
0
7.17
2021-03
0
11.5
2021-04
0
12
2021-05
0
8.33
2021-06
0
13.17
2021-07
0
11.17
2021-08
0
13
2021-09
0
10.33
2021-10
0
11.33
2021-11
0
16.2
2021-12
0
12.4
2022-01
0
15.2
2022-02
0
9.6
2022-03
0
9.86
2022-04
0
7.67
2022-05
0
23.67
2022-06
0
11.2
2022-07
0
13.8
2022-08
0
11.63
2022-09
0
10.83
2022-10
0
8.71
2022-11
0
12.5
2022-12
0
13
2023-01
0
6
2023-02
0
11.67
2023-03
0
14.8
2023-04
0
16.5
2023-05
0
11.2
2023-06
0
8.5
2023-07
0
17
2023-08
0
6.38
2023-09
0
14.6
2023-10
0
17.25
2023-11
0
12.2
2023-12
0
13.5
2024-01
0
13.83
2024-02
0
17.5
2024-03
0
11.5
2024-04
0
10
2024-05
0
14.4
2024-06
0
8.86
2024-07
0
10.57
2024-08
0
9.29
2024-09
0
9
2024-10
0
6.89
2024-11
0
10.5
2024-12
0
4
2025-01
0
7.14
2025-02
0
5.17
2025-03
0
6
2025-04
0
5.75
2025-05
0
4.17
2025-06
0
8.33
2025-07
0
5
2025-08
0
5
2025-09
0
4.86
2025-10
0
7
2025-11
0
5.2
2025-12
0
4.7
2026-01
0
10.5
2026-02
0
3.33
2026-03
2
6.38
2026-04
0
4.25
2026-05
0
6.88
2026-06
0
3.63
This device (reports/month)Average device in NTE (reports/device/month)
Failure-mode summaryAI-generated
2 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.