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.
65 linked reportsInjury 64Malfunction 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
4
2.99
2019-02
0
2.56
2019-03
0
2.88
2019-04
0
2.72
2019-05
3
2.13
2019-06
0
1.85
2019-07
2
1.85
2019-08
2
2.16
2019-09
0
2.36
2019-10
6
2.57
2019-11
1
2.16
2019-12
0
2.45
2020-01
0
2.81
2020-02
2
2.54
2020-03
1
3.24
2020-04
1
2.27
2020-05
1
2.22
2020-06
2
2.06
2020-07
2
2.55
2020-08
0
2.03
2020-09
1
2.53
2020-10
0
2.53
2020-11
0
2.31
2020-12
1
2.32
2021-01
3
2.44
2021-02
2
2.05
2021-03
1
2.05
2021-04
1
2.07
2021-05
2
1.99
2021-06
0
2.49
2021-07
2
2.34
2021-08
1
2.29
2021-09
1
2.42
2021-10
4
2.21
2021-11
0
2.09
2021-12
0
2.32
2022-01
0
2.08
2022-02
0
2.12
2022-03
2
2.18
2022-04
0
2.17
2022-05
2
2.14
2022-06
0
2.24
2022-07
0
2.12
2022-08
1
2.22
2022-09
2
2.22
2022-10
0
2.18
2022-11
0
2.27
2022-12
1
2.18
2023-01
0
2.27
2023-02
0
2.16
2023-03
1
2.36
2023-04
0
2.31
2023-05
2
2.24
2023-06
0
2.34
2023-07
0
2.21
2023-08
0
2.06
2023-09
0
2.07
2023-10
0
1.72
2023-11
0
1.68
2023-12
0
1.77
2024-01
1
1.78
2024-02
0
2.1
2024-03
1
2.05
2024-04
0
1.84
2024-05
1
2.25
2024-06
0
2.03
2024-07
0
1.78
2024-08
0
2.01
2024-09
1
2.12
2024-10
1
1.84
2024-11
0
1.77
2024-12
0
1.61
2025-01
0
1.94
2025-02
1
1.56
2025-03
0
1.78
2025-04
0
1.83
2025-05
1
1.73
2025-06
0
1.85
2025-07
0
1.83
2025-08
0
1.73
2025-09
0
1.75
2025-10
0
1.73
2025-11
0
1.81
2025-12
0
1.9
2026-01
0
1.98
2026-02
0
1.68
2026-03
0
2.01
2026-04
1
1.89
2026-05
0
1.75
2026-06
0
1.79
This device (reports/month)Average device in JDI, LPH, LWJ, LZO, 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.