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.
8 linked reportsInjury 6Malfunction 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
3.32
2019-02
0
2.85
2019-03
0
3.29
2019-04
0
3.04
2019-05
0
2.32
2019-06
0
2
2019-07
0
1.96
2019-08
0
2.36
2019-09
0
2.66
2019-10
0
2.96
2019-11
0
2.47
2019-12
1
2.82
2020-01
0
3.31
2020-02
0
2.83
2020-03
0
3.61
2020-04
0
2.56
2020-05
0
2.44
2020-06
0
2.36
2020-07
0
2.82
2020-08
0
2.3
2020-09
0
2.95
2020-10
0
2.92
2020-11
0
2.64
2020-12
0
2.63
2021-01
0
2.79
2021-02
0
2.32
2021-03
0
2.31
2021-04
0
2.35
2021-05
2
2.23
2021-06
0
2.8
2021-07
0
2.65
2021-08
0
2.71
2021-09
0
2.78
2021-10
0
2.48
2021-11
0
2.34
2021-12
0
2.62
2022-01
0
2.39
2022-02
0
2.25
2022-03
0
2.54
2022-04
0
2.4
2022-05
0
2.42
2022-06
0
2.54
2022-07
0
2.37
2022-08
0
2.43
2022-09
2
2.47
2022-10
0
2.44
2022-11
0
2.52
2022-12
0
2.56
2023-01
0
2.65
2023-02
0
2.47
2023-03
0
2.74
2023-04
0
2.58
2023-05
0
2.46
2023-06
0
2.54
2023-07
0
2.32
2023-08
0
2.11
2023-09
0
2.09
2023-10
0
1.86
2023-11
1
1.79
2023-12
0
1.91
2024-01
0
1.89
2024-02
0
2.28
2024-03
0
2.07
2024-04
0
1.92
2024-05
0
2.2
2024-06
0
2.04
2024-07
0
1.86
2024-08
0
2.02
2024-09
0
2.19
2024-10
0
1.94
2024-11
0
2
2024-12
0
1.69
2025-01
0
2.18
2025-02
2
1.66
2025-03
0
1.88
2025-04
0
1.93
2025-05
0
1.93
2025-06
0
1.97
2025-07
0
1.96
2025-08
0
1.9
2025-09
0
1.82
2025-10
0
1.83
2025-11
0
1.88
2025-12
0
2
2026-01
0
2.06
2026-02
0
1.78
2026-03
0
2.01
2026-04
0
2.03
2026-05
0
1.84
2026-06
0
1.87
This device (reports/month)Average device in LPH, LZO (reports/device/month)
Failure-mode summaryAI-generated
8 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.