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.
2 linked reportsInjury 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
1.77
2019-02
0
1.78
2019-03
0
1.42
2019-04
0
1.51
2019-05
0
1.62
2019-06
0
1.9
2019-07
0
1.54
2019-08
0
1.46
2019-09
0
1.37
2019-10
0
1.54
2019-11
0
1.32
2019-12
0
2.25
2020-01
0
1.56
2020-02
0
1.8
2020-03
0
2.5
2020-04
0
1.85
2020-05
0
1.44
2020-06
0
3.45
2020-07
0
4.3
2020-08
0
4.04
2020-09
0
3.65
2020-10
0
4.49
2020-11
0
4.62
2020-12
0
6.89
2021-01
0
4.59
2021-02
0
5.04
2021-03
0
2.55
2021-04
0
2.34
2021-05
0
4.35
2021-06
0
4.25
2021-07
0
3.72
2021-08
1
4.1
2021-09
0
5.22
2021-10
0
3.36
2021-11
0
3.65
2021-12
0
3.7
2022-01
0
3.45
2022-02
0
4.9
2022-03
0
4.12
2022-04
0
4.15
2022-05
0
6.31
2022-06
0
3.39
2022-07
0
4.53
2022-08
0
3.43
2022-09
0
2.92
2022-10
0
3.98
2022-11
0
3.28
2022-12
0
4
2023-01
0
4.36
2023-02
0
3.3
2023-03
0
2.46
2023-04
0
4.15
2023-05
0
3.16
2023-06
0
3.73
2023-07
0
2.36
2023-08
0
2.22
2023-09
0
1.91
2023-10
0
2.17
2023-11
0
2.82
2023-12
0
2.07
2024-01
0
2.93
2024-02
0
2.34
2024-03
0
2.52
2024-04
0
2.88
2024-05
0
1.89
2024-06
0
2.34
2024-07
0
2.96
2024-08
0
2.73
2024-09
0
2.57
2024-10
0
2.26
2024-11
0
2.1
2024-12
0
2.91
2025-01
0
2.17
2025-02
0
2.1
2025-03
0
2.12
2025-04
0
2.27
2025-05
0
2.21
2025-06
0
1.89
2025-07
0
2.48
2025-08
0
1.79
2025-09
0
2.36
2025-10
0
2.55
2025-11
1
1.91
2025-12
0
2.54
2026-01
0
1.67
2026-02
0
2.14
2026-03
0
2.26
2026-04
0
1.97
2026-05
0
2.54
2026-06
0
1.97
This device (reports/month)Average device in HRY, NPJ (reports/device/month)
Failure-mode summaryAI-generated
2 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.