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.
47 linked reportsMalfunction 46Injury 1
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
2.89
2019-02
0
2.47
2019-03
0
2.82
2019-04
0
2.66
2019-05
0
2.12
2019-06
0
1.81
2019-07
0
1.83
2019-08
0
2.07
2019-09
0
2.29
2019-10
0
2.49
2019-11
0
2.09
2019-12
0
2.38
2020-01
1
2.69
2020-02
0
2.42
2020-03
0
3.04
2020-04
1
2.16
2020-05
0
2.14
2020-06
1
1.95
2020-07
0
2.37
2020-08
0
1.96
2020-09
0
2.44
2020-10
0
2.37
2020-11
0
2.22
2020-12
0
2.24
2021-01
0
2.38
2021-02
0
1.98
2021-03
0
1.96
2021-04
0
1.97
2021-05
0
1.93
2021-06
0
2.36
2021-07
0
2.23
2021-08
1
2.17
2021-09
0
2.29
2021-10
0
2.11
2021-11
0
1.98
2021-12
0
2.22
2022-01
0
1.99
2022-02
0
1.97
2022-03
1
2.05
2022-04
0
2.05
2022-05
0
2.04
2022-06
0
2.13
2022-07
0
1.98
2022-08
0
2.05
2022-09
0
2.08
2022-10
0
2.02
2022-11
0
2.1
2022-12
0
2.05
2023-01
0
2.14
2023-02
1
1.99
2023-03
0
2.22
2023-04
0
2.14
2023-05
0
2.06
2023-06
0
2.14
2023-07
0
2
2023-08
0
1.87
2023-09
0
1.91
2023-10
0
1.6
2023-11
0
1.57
2023-12
0
1.67
2024-01
2
1.69
2024-02
0
1.98
2024-03
0
1.88
2024-04
0
1.7
2024-05
0
1.98
2024-06
2
1.83
2024-07
0
1.67
2024-08
0
1.8
2024-09
0
1.89
2024-10
0
1.72
2024-11
1
1.67
2024-12
2
1.52
2025-01
2
1.86
2025-02
0
1.5
2025-03
8
1.79
2025-04
6
1.8
2025-05
2
1.65
2025-06
0
1.8
2025-07
1
1.78
2025-08
0
1.63
2025-09
0
1.69
2025-10
1
1.68
2025-11
0
1.74
2025-12
2
1.88
2026-01
1
1.94
2026-02
0
1.6
2026-03
2
1.91
2026-04
5
1.86
2026-05
1
1.63
2026-06
3
1.68
This device (reports/month)Average device in JDI, JDL, KWA, KWH, KWY, KWZ, LPH, LZO, MEH, OQG (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.