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.
91 linked reportsInjury 87Malfunction 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
1.71
2019-02
1
1.54
2019-03
1
1.66
2019-04
1
1.53
2019-05
4
1.78
2019-06
0
1.84
2019-07
1
1.38
2019-08
2
1.99
2019-09
0
1.51
2019-10
2
1.76
2019-11
0
1.63
2019-12
0
1.72
2020-01
0
1.95
2020-02
0
2.16
2020-03
2
1.64
2020-04
2
1.7
2020-05
1
1.51
2020-06
0
1.83
2020-07
2
1.94
2020-08
0
1.73
2020-09
1
1.95
2020-10
2
2
2020-11
0
1.83
2020-12
1
1.79
2021-01
2
1.93
2021-02
0
1.92
2021-03
3
2.02
2021-04
0
1.87
2021-05
0
1.78
2021-06
0
1.58
2021-07
0
1.92
2021-08
0
2.1
2021-09
1
1.74
2021-10
0
1.82
2021-11
0
1.99
2021-12
2
1.92
2022-01
0
2.14
2022-02
3
2.1
2022-03
1
1.77
2022-04
0
2.07
2022-05
2
1.93
2022-06
2
2.03
2022-07
1
2.15
2022-08
0
1.98
2022-09
1
1.88
2022-10
2
1.87
2022-11
0
1.93
2022-12
1
1.81
2023-01
1
1.75
2023-02
1
1.83
2023-03
0
1.96
2023-04
0
1.94
2023-05
1
2.01
2023-06
3
2.21
2023-07
3
2
2023-08
0
1.61
2023-09
0
1.44
2023-10
0
1.57
2023-11
1
1.56
2023-12
1
1.39
2024-01
1
1.81
2024-02
2
1.64
2024-03
1
1.59
2024-04
4
1.74
2024-05
0
1.59
2024-06
3
1.88
2024-07
0
1.5
2024-08
1
1.68
2024-09
2
1.61
2024-10
0
1.59
2024-11
0
1.51
2024-12
2
1.55
2025-01
1
1.67
2025-02
1
1.52
2025-03
1
1.78
2025-04
2
1.58
2025-05
2
1.66
2025-06
2
1.76
2025-07
0
1.66
2025-08
2
1.51
2025-09
1
1.48
2025-10
0
1.56
2025-11
0
1.74
2025-12
2
2.08
2026-01
0
1.81
2026-02
2
1.79
2026-03
2
1.66
2026-04
0
1.69
2026-05
1
1.65
2026-06
1
1.68
This device (reports/month)Average device in HSD, KWS (reports/device/month)
Failure-mode summaryAI-generated
40 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.