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.
4 linked reportsInjury 4
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
1.78
2019-02
1
1.74
2019-03
0
1.44
2019-04
0
1.52
2019-05
0
1.6
2019-06
0
1.89
2019-07
0
1.52
2019-08
0
1.47
2019-09
0
1.4
2019-10
0
1.58
2019-11
0
1.28
2019-12
0
2.17
2020-01
0
1.53
2020-02
0
1.82
2020-03
1
2.53
2020-04
1
1.79
2020-05
0
1.41
2020-06
0
3.38
2020-07
0
4.26
2020-08
0
3.87
2020-09
0
3.49
2020-10
0
4.37
2020-11
0
4.49
2020-12
0
6.4
2021-01
0
4.32
2021-02
0
5.04
2021-03
0
2.52
2021-04
0
2.33
2021-05
0
4.18
2021-06
0
4.22
2021-07
0
3.66
2021-08
0
3.93
2021-09
0
5.1
2021-10
0
3.29
2021-11
0
3.54
2021-12
0
3.66
2022-01
0
3.35
2022-02
0
4.62
2022-03
0
4.08
2022-04
0
4.06
2022-05
0
6.23
2022-06
0
3.43
2022-07
0
4.45
2022-08
0
3.38
2022-09
0
2.86
2022-10
0
3.88
2022-11
0
3.11
2022-12
0
4
2023-01
0
4.38
2023-02
0
3.29
2023-03
0
2.44
2023-04
0
4.04
2023-05
0
3.15
2023-06
0
3.64
2023-07
0
2.38
2023-08
0
2.18
2023-09
0
1.91
2023-10
0
2.15
2023-11
0
2.81
2023-12
0
2.03
2024-01
0
2.84
2024-02
0
2.33
2024-03
1
2.38
2024-04
0
2.79
2024-05
0
1.91
2024-06
0
2.33
2024-07
0
2.96
2024-08
0
2.46
2024-09
0
2.44
2024-10
0
2.2
2024-11
0
2.1
2024-12
0
2.82
2025-01
0
2.15
2025-02
0
2.03
2025-03
0
2.09
2025-04
0
2.26
2025-05
0
2.19
2025-06
0
1.91
2025-07
0
2.42
2025-08
0
1.77
2025-09
0
2.31
2025-10
0
2.5
2025-11
0
1.96
2025-12
0
2.5
2026-01
0
1.64
2026-02
0
2.1
2026-03
0
2.24
2026-04
0
1.94
2026-05
0
2.47
2026-06
0
1.97
This device (reports/month)Average device in HRY, KRR, NPJ (reports/device/month)
Failure-mode summaryAI-generated
4 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.