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.
3 linked reportsInjury 3
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
6.58
2019-02
0
7.06
2019-03
0
7.6
2019-04
0
5.74
2019-05
0
5.7
2019-06
0
7.96
2019-07
0
5.54
2019-08
0
7.27
2019-09
0
6.86
2019-10
0
8.29
2019-11
0
6.84
2019-12
0
7.11
2020-01
0
6.49
2020-02
0
6.93
2020-03
0
9.6
2020-04
0
5.82
2020-05
0
6.07
2020-06
0
5.56
2020-07
0
6.66
2020-08
0
5.26
2020-09
0
5.57
2020-10
0
5.04
2020-11
0
4.8
2020-12
0
7.3
2021-01
0
7.81
2021-02
0
9.12
2021-03
0
7.87
2021-04
0
5.99
2021-05
0
8.19
2021-06
0
7.39
2021-07
0
7.95
2021-08
0
7.37
2021-09
0
6.03
2021-10
0
6.91
2021-11
0
7.26
2021-12
0
5.1
2022-01
0
4.13
2022-02
0
5.61
2022-03
0
4.39
2022-04
0
6.62
2022-05
0
4.93
2022-06
0
4.79
2022-07
0
4.76
2022-08
0
5.41
2022-09
0
4.09
2022-10
0
6.06
2022-11
0
4.41
2022-12
0
5.1
2023-01
0
5
2023-02
0
6.14
2023-03
0
5.91
2023-04
0
4.66
2023-05
0
5.49
2023-06
0
4.33
2023-07
0
4.87
2023-08
0
4.69
2023-09
0
3.61
2023-10
0
4.7
2023-11
0
4.2
2023-12
0
3.71
2024-01
0
3.45
2024-02
0
4.34
2024-03
0
4.65
2024-04
0
3.97
2024-05
0
4.63
2024-06
0
4.36
2024-07
0
4.03
2024-08
0
5.4
2024-09
0
4.29
2024-10
0
4.81
2024-11
0
4.58
2024-12
0
4.58
2025-01
0
4.69
2025-02
0
4.77
2025-03
0
6.04
2025-04
0
5.59
2025-05
0
4.73
2025-06
0
5.45
2025-07
0
5.54
2025-08
0
6.29
2025-09
2
5.02
2025-10
1
5.32
2025-11
0
4.87
2025-12
0
5.38
2026-01
0
5.92
2026-02
0
5.95
2026-03
0
5.65
2026-04
0
5.4
2026-05
0
5.64
2026-06
0
6.54
This device (reports/month)Average device in GEX, ILY, ONF (reports/device/month)
Failure-mode summaryAI-generated
3 linked report narratives available — no AI summary generated yet.