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.
17 linked reportsInjury 17
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
1.75
2019-02
0
1.73
2019-03
0
1.46
2019-04
0
1.65
2019-05
0
1.64
2019-06
0
1.87
2019-07
0
1.5
2019-08
0
1.51
2019-09
0
1.49
2019-10
0
1.64
2019-11
0
1.27
2019-12
0
2.12
2020-01
0
1.51
2020-02
0
1.88
2020-03
2
2.57
2020-04
0
1.61
2020-05
0
1.35
2020-06
0
3.15
2020-07
0
3.73
2020-08
0
3.67
2020-09
0
3.18
2020-10
0
3.97
2020-11
0
4.15
2020-12
0
5.34
2021-01
0
3.92
2021-02
0
4.53
2021-03
0
2.44
2021-04
0
2.39
2021-05
0
3.75
2021-06
0
4.03
2021-07
0
3.54
2021-08
0
3.54
2021-09
0
4.52
2021-10
0
3.37
2021-11
3
3.36
2021-12
0
3.51
2022-01
0
3.11
2022-02
3
4.21
2022-03
0
3.94
2022-04
0
3.72
2022-05
0
4.68
2022-06
0
3.1
2022-07
0
4.13
2022-08
0
3.02
2022-09
0
3.98
2022-10
0
3.44
2022-11
0
2.88
2022-12
0
3.16
2023-01
0
3.63
2023-02
0
3.1
2023-03
3
2.44
2023-04
0
3.04
2023-05
0
2.89
2023-06
0
3.47
2023-07
0
2.33
2023-08
2
2.24
2023-09
0
1.76
2023-10
0
2.05
2023-11
2
2.58
2023-12
0
1.91
2024-01
2
2.8
2024-02
0
2.15
2024-03
0
2.2
2024-04
0
2.57
2024-05
0
1.87
2024-06
0
2.11
2024-07
0
2.75
2024-08
0
2.1
2024-09
0
2.21
2024-10
0
2.08
2024-11
0
1.95
2024-12
0
2.61
2025-01
0
2.07
2025-02
0
1.91
2025-03
0
1.98
2025-04
0
2.07
2025-05
0
2
2025-06
0
1.83
2025-07
0
2.32
2025-08
0
1.81
2025-09
0
2.15
2025-10
0
2.21
2025-11
0
1.91
2025-12
0
2.1
2026-01
0
1.71
2026-02
0
2.05
2026-03
0
2.25
2026-04
0
1.85
2026-05
0
2.36
2026-06
0
2.03
This device (reports/month)Average device in HRY, HSX, KRR, NPJ (reports/device/month)
Failure-mode summaryAI-generated
17 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.