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
2.71
2019-02
0
3.25
2019-03
0
3.75
2019-04
0
3.25
2019-05
0
3.8
2019-06
0
3.33
2019-07
0
3.2
2019-08
0
2.5
2019-09
0
5.25
2019-10
0
4.1
2019-11
0
3.5
2019-12
0
3.83
2020-01
0
2.38
2020-02
0
2.86
2020-03
0
3.11
2020-04
0
3.4
2020-05
0
3
2020-06
0
4.6
2020-07
0
3.64
2020-08
0
2.33
2020-09
0
4.5
2020-10
0
3
2020-11
0
7.33
2020-12
0
3.13
2021-01
0
2.44
2021-02
0
2.56
2021-03
0
5
2021-04
0
2.88
2021-05
0
4.17
2021-06
0
2.16
2021-07
0
3
2021-08
0
1.29
2021-09
0
1.8
2021-10
0
1.33
2021-11
0
2.33
2021-12
0
2.25
2022-01
0
1.5
2022-02
0
1.75
2022-03
0
1.33
2022-04
0
1.9
2022-05
0
1
2022-06
0
2.17
2022-07
0
2.07
2022-08
0
1.33
2022-09
0
1.25
2022-10
0
1.71
2022-11
0
2.4
2022-12
0
1
2023-01
0
1.5
2023-02
0
1
2023-03
0
1.22
2023-04
0
1.64
2023-05
0
1.2
2023-06
0
1.25
2023-07
0
1.73
2023-08
0
1.43
2023-09
0
2
2023-10
0
1.88
2023-11
0
2
2023-12
0
1.57
2024-01
0
1.31
2024-02
0
1.44
2024-03
0
1.6
2024-04
0
1.56
2024-05
0
1.33
2024-06
0
1
2024-07
0
1.67
2024-08
0
1.57
2024-09
0
2.09
2024-10
1
1.45
2024-11
0
1.46
2024-12
0
1.5
2025-01
0
1.53
2025-02
2
1.71
2025-03
1
1.55
2025-04
0
1.61
2025-05
0
1.82
2025-06
0
1.44
2025-07
0
1.47
2025-08
0
3.25
2025-09
0
1.33
2025-10
0
2
2025-11
0
1.43
2025-12
0
2.33
2026-01
0
2
2026-02
0
1
2026-03
0
1.25
2026-04
0
1.84
2026-05
0
2.71
2026-06
0
3.74
This device (reports/month)Average device in HBB (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.