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.
22 linked reportsInjury 20Malfunction 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
1.9
2019-02
0
1.96
2019-03
0
1.62
2019-04
0
1.9
2019-05
0
1.74
2019-06
0
2.03
2019-07
0
1.94
2019-08
0
2.11
2019-09
1
1.86
2019-10
0
2.21
2019-11
0
2.73
2019-12
0
2.22
2020-01
0
2.22
2020-02
1
2.55
2020-03
0
2.11
2020-04
0
2.02
2020-05
1
1.71
2020-06
1
1.96
2020-07
1
2.49
2020-08
0
2.54
2020-09
0
2.1
2020-10
1
2.65
2020-11
0
2.59
2020-12
0
2.69
2021-01
0
2.25
2021-02
1
2.24
2021-03
0
2.39
2021-04
0
2.21
2021-05
0
2.16
2021-06
0
2.05
2021-07
0
2.04
2021-08
0
1.75
2021-09
0
2.13
2021-10
1
1.81
2021-11
0
2.1
2021-12
1
2.16
2022-01
0
1.87
2022-02
0
2.2
2022-03
3
1.87
2022-04
0
1.93
2022-05
1
2.11
2022-06
0
1.87
2022-07
0
1.92
2022-08
0
1.94
2022-09
0
2.07
2022-10
0
2.04
2022-11
0
2.1
2022-12
0
1.77
2023-01
0
1.92
2023-02
0
2.05
2023-03
0
2.04
2023-04
0
2.1
2023-05
0
2.22
2023-06
0
2.1
2023-07
1
1.87
2023-08
0
1.59
2023-09
0
1.64
2023-10
0
1.53
2023-11
0
1.59
2023-12
1
1.59
2024-01
0
1.47
2024-02
0
1.63
2024-03
1
1.68
2024-04
2
1.56
2024-05
0
1.76
2024-06
0
1.84
2024-07
0
1.7
2024-08
0
2.16
2024-09
0
1.85
2024-10
2
1.85
2024-11
0
1.81
2024-12
0
1.92
2025-01
0
2.12
2025-02
0
1.71
2025-03
0
1.69
2025-04
0
1.56
2025-05
1
1.61
2025-06
0
1.68
2025-07
0
1.53
2025-08
0
1.56
2025-09
0
1.53
2025-10
1
1.38
2025-11
0
1.58
2025-12
0
1.57
2026-01
0
1.47
2026-02
0
1.46
2026-03
0
1.81
2026-04
0
1.62
2026-05
0
1.59
2026-06
0
1.57
This device (reports/month)Average device in JWH, MBH (reports/device/month)
Failure-mode summaryAI-generated
22 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.