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 47
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
2.8
2019-02
0
2.41
2019-03
0
2.73
2019-04
0
2.61
2019-05
0
2.07
2019-06
0
1.76
2019-07
0
1.78
2019-08
0
2.03
2019-09
0
2.23
2019-10
0
2.41
2019-11
0
2.04
2019-12
0
2.32
2020-01
0
2.66
2020-02
0
2.37
2020-03
0
3
2020-04
0
2.13
2020-05
0
2.11
2020-06
0
1.95
2020-07
0
2.39
2020-08
1
1.91
2020-09
0
2.38
2020-10
0
2.37
2020-11
0
2.19
2020-12
1
2.21
2021-01
0
2.35
2021-02
2
1.95
2021-03
0
1.94
2021-04
0
1.95
2021-05
0
1.91
2021-06
0
2.35
2021-07
0
2.2
2021-08
0
2.15
2021-09
2
2.28
2021-10
0
2.11
2021-11
0
1.97
2021-12
0
2.18
2022-01
0
1.97
2022-02
1
1.98
2022-03
2
2.04
2022-04
1
2.06
2022-05
2
2.04
2022-06
2
2.12
2022-07
0
1.98
2022-08
0
2.05
2022-09
1
2.08
2022-10
1
2.03
2022-11
0
2.12
2022-12
3
2.05
2023-01
0
2.15
2023-02
2
2.01
2023-03
2
2.21
2023-04
2
2.14
2023-05
2
2.08
2023-06
1
2.13
2023-07
2
2.02
2023-08
2
1.89
2023-09
0
1.9
2023-10
1
1.6
2023-11
1
1.57
2023-12
1
1.66
2024-01
1
1.69
2024-02
0
1.98
2024-03
1
1.9
2024-04
0
1.69
2024-05
0
1.99
2024-06
1
1.84
2024-07
1
1.67
2024-08
1
1.83
2024-09
0
1.92
2024-10
0
1.73
2024-11
1
1.67
2024-12
0
1.53
2025-01
0
1.84
2025-02
0
1.49
2025-03
1
1.77
2025-04
0
1.78
2025-05
1
1.66
2025-06
1
1.79
2025-07
0
1.79
2025-08
0
1.64
2025-09
0
1.68
2025-10
1
1.69
2025-11
0
1.75
2025-12
0
1.84
2026-01
0
1.92
2026-02
0
1.59
2026-03
1
1.89
2026-04
1
1.83
2026-05
0
1.64
2026-06
0
1.69
This device (reports/month)Average device in JDI, KWY, KWZ, LPH, LZO, MAY, MEH (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.