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.
4 linked reportsMalfunction 4
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
15.5
2019-03
0
29
2019-04
0
15
2019-05
0
11.67
2019-06
0
14.33
2019-07
0
10.33
2019-08
0
15.67
2019-09
0
8.2
2019-10
0
15.33
2019-11
0
14.67
2019-12
0
13.25
2020-01
0
22
2020-02
0
20
2020-03
0
20.5
2020-04
0
34
2020-05
0
6
2020-06
0
6.7
2020-07
0
7.57
2020-08
0
8.33
2020-09
0
10.4
2020-10
0
6.55
2020-11
0
10.33
2020-12
0
8.71
2021-01
0
6.67
2021-02
0
5.71
2021-03
0
7.4
2021-04
0
9.17
2021-05
0
7.67
2021-06
0
6.78
2021-07
0
6.2
2021-08
0
10.4
2021-09
0
11.8
2021-10
0
9.75
2021-11
0
5.5
2021-12
0
8.25
2022-01
0
15.5
2022-02
0
4.36
2022-03
0
8.14
2022-04
0
7.4
2022-05
0
6
2022-06
0
10.17
2022-07
0
14
2022-08
2
6.63
2022-09
0
14
2022-10
0
9.33
2022-11
0
8.17
2022-12
0
11.75
2023-01
0
10
2023-02
0
8.2
2023-03
0
8.25
2023-04
0
9
2023-05
0
10.75
2023-06
0
11.2
2023-07
0
9.67
2023-08
0
6.67
2023-09
0
6.4
2023-10
0
7.25
2023-11
0
14
2023-12
0
6.25
2024-01
0
14.75
2024-02
0
5.6
2024-03
0
7.75
2024-04
0
5.2
2024-05
0
3.6
2024-06
0
7
2024-07
0
5.17
2024-08
0
5
2024-09
0
8
2024-10
0
7.33
2024-11
0
3.8
2024-12
0
4.83
2025-01
0
5.4
2025-02
0
3
2025-03
0
4.2
2025-04
0
3.83
2025-05
0
2.6
2025-06
0
4.33
2025-07
0
6.25
2025-08
0
5.33
2025-09
0
3
2025-10
0
3.2
2025-11
0
3.43
2025-12
0
3
2026-01
0
3
2026-02
0
2.75
2026-03
1
2.6
2026-04
0
6
2026-05
0
3.33
2026-06
1
3
This device (reports/month)Average device in HBF (reports/device/month)
Failure-mode summaryAI-generated
4 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.