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.
5 linked reportsInjury 5
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
2.97
2019-02
0
2.55
2019-03
0
2.61
2019-04
0
2.64
2019-05
0
2.15
2019-06
0
2.09
2019-07
0
2.06
2019-08
0
2.25
2019-09
0
2.38
2019-10
1
2.65
2019-11
0
2.59
2019-12
1
2.56
2020-01
0
2.74
2020-02
0
2.78
2020-03
0
3.01
2020-04
0
2.33
2020-05
0
2.17
2020-06
2
2.28
2020-07
0
2.78
2020-08
0
2.57
2020-09
0
2.58
2020-10
0
2.96
2020-11
0
2.89
2020-12
0
3.04
2021-01
0
2.73
2021-02
0
2.51
2021-03
0
2.4
2021-04
0
2.35
2021-05
0
2.45
2021-06
0
2.6
2021-07
0
2.5
2021-08
0
2.28
2021-09
0
2.59
2021-10
0
2.22
2021-11
0
2.39
2021-12
0
2.57
2022-01
0
2.22
2022-02
0
2.49
2022-03
0
2.37
2022-04
0
2.35
2022-05
0
2.48
2022-06
0
2.34
2022-07
0
2.28
2022-08
0
2.27
2022-09
0
2.42
2022-10
0
2.31
2022-11
0
2.35
2022-12
0
2.18
2023-01
0
2.23
2023-02
0
2.27
2023-03
0
2.37
2023-04
0
2.34
2023-05
0
2.37
2023-06
0
2.38
2023-07
0
2.12
2023-08
0
1.95
2023-09
0
1.9
2023-10
1
1.69
2023-11
0
1.74
2023-12
0
1.73
2024-01
0
1.76
2024-02
0
1.98
2024-03
0
1.92
2024-04
0
1.77
2024-05
0
2
2024-06
0
1.99
2024-07
0
1.85
2024-08
0
2.1
2024-09
0
2.13
2024-10
0
1.92
2024-11
0
1.89
2024-12
0
1.88
2025-01
0
2.12
2025-02
0
1.7
2025-03
0
1.82
2025-04
0
1.81
2025-05
0
1.77
2025-06
0
1.84
2025-07
0
1.76
2025-08
0
1.71
2025-09
0
1.74
2025-10
0
1.64
2025-11
0
1.79
2025-12
0
1.84
2026-01
0
1.82
2026-02
0
1.61
2026-03
0
2.02
2026-04
0
1.82
2026-05
0
1.75
2026-06
0
1.74
This device (reports/month)Average device in HRY, HSX, JDB, JDI, JWH, KWT, LPH (reports/device/month)
Failure-mode summaryAI-generated
5 linked report narratives available — no AI summary generated yet.