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
1.76
2019-02
0
1.38
2019-03
0
1.64
2019-04
0
1
2019-05
0
1.17
2019-06
0
3
2019-07
0
1.83
2019-08
0
1.53
2019-09
0
1.05
2019-10
0
1.75
2019-11
0
1.36
2019-12
0
1.7
2020-01
0
1.91
2020-02
0
1.44
2020-03
0
1.52
2020-04
0
3.33
2020-05
0
1
2020-06
0
1.5
2020-07
0
2.25
2020-08
0
1.6
2020-09
0
1.63
2020-10
0
1.92
2020-11
0
1
2020-12
0
2.5
2021-01
0
1.25
2021-02
0
2.93
2021-03
0
1.25
2021-04
0
1.91
2021-05
0
1.42
2021-06
0
2.31
2021-07
0
2
2021-08
1
1.69
2021-09
0
1.5
2021-10
1
1.14
2021-11
0
1
2021-12
0
1.27
2022-01
0
1.63
2022-02
0
1.63
2022-03
0
1.17
2022-04
0
2.8
2022-05
0
3
2022-06
0
1.71
2022-07
0
1.38
2022-08
0
1.5
2022-09
0
1.7
2022-10
0
1.14
2022-11
0
1.22
2022-12
0
1
2023-01
0
1
2023-02
0
1
2023-03
0
2
2023-04
0
1.29
2023-05
0
1
2023-06
0
6.5
2023-07
0
1.67
2023-08
0
2.33
2023-09
0
4.83
2023-10
0
1.18
2023-11
0
3.5
2023-12
0
2.29
2024-01
0
1.08
2024-02
0
1.14
2024-03
0
1
2024-04
0
1
2024-05
0
3.5
2024-06
0
1
2024-07
0
2.5
2024-08
0
2.5
2024-09
0
1.15
2024-10
0
2.2
2024-11
0
1.33
2024-12
0
2.5
2025-01
0
1.29
2025-02
0
1
2025-03
0
1.6
2025-04
0
1.5
2025-05
0
1
2025-06
0
1.4
2025-07
0
1
2025-08
0
1.5
2025-09
0
1.75
2025-10
0
1.25
2025-11
0
1.57
2025-12
0
1.13
2026-01
0
3.2
2026-02
0
5.43
2026-03
0
4.8
2026-04
0
1.2
2026-05
0
1.5
2026-06
0
1.17
This device (reports/month)Average device in DXT (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.