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
1.37
2019-02
0
1.37
2019-03
0
1.48
2019-04
0
1.49
2019-05
0
1.17
2019-06
0
1.12
2019-07
0
1.11
2019-08
0
1.13
2019-09
0
1.61
2019-10
0
1.62
2019-11
0
2.63
2019-12
0
1.2
2020-01
0
1.19
2020-02
0
1.77
2020-03
0
1.66
2020-04
0
2.65
2020-05
0
1.44
2020-06
0
1.2
2020-07
0
1.89
2020-08
0
1.9
2020-09
0
4.48
2020-10
0
2.06
2020-11
0
1.27
2020-12
2
1.97
2021-01
0
1.27
2021-02
0
1.19
2021-03
0
1.33
2021-04
0
1.88
2021-05
0
1.77
2021-06
0
1.3
2021-07
0
1.91
2021-08
0
2
2021-09
0
1.26
2021-10
0
1.87
2021-11
0
1.9
2021-12
0
3.67
2022-01
0
3.14
2022-02
0
1.43
2022-03
0
1.81
2022-04
0
1.38
2022-05
1
1.13
2022-06
0
1.11
2022-07
0
1.36
2022-08
0
1.82
2022-09
0
1.1
2022-10
0
3.21
2022-11
0
1.13
2022-12
0
1.13
2023-01
0
1.14
2023-02
0
1.13
2023-03
0
1.85
2023-04
0
2.6
2023-05
0
1.12
2023-06
0
1.81
2023-07
0
1.89
2023-08
0
1.51
2023-09
0
1.4
2023-10
0
1.45
2023-11
0
1.53
2023-12
0
1.29
2024-01
0
1.55
2024-02
0
1.3
2024-03
0
1.43
2024-04
0
1.38
2024-05
0
1.37
2024-06
0
1.4
2024-07
0
1.42
2024-08
0
1.34
2024-09
0
1.54
2024-10
0
1.54
2024-11
0
1.65
2024-12
0
1.75
2025-01
0
1.56
2025-02
0
1.86
2025-03
0
1.71
2025-04
0
1.71
2025-05
0
1.65
2025-06
0
1.94
2025-07
0
1.84
2025-08
0
1.74
2025-09
0
1.63
2025-10
0
1.85
2025-11
0
1.54
2025-12
0
2.05
2026-01
0
1.72
2026-02
0
1.81
2026-03
0
1.73
2026-04
0
2.01
2026-05
0
1.89
2026-06
0
1.84
This device (reports/month)Average device in KRD (reports/device/month)
Failure-mode summaryAI-generated
3 linked report narratives available — no AI summary generated yet.