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
2.59
2019-02
0
1.9
2019-03
0
1.83
2019-04
0
2.32
2019-05
0
1.67
2019-06
0
1.96
2019-07
0
2.44
2019-08
0
2.05
2019-09
0
1.67
2019-10
0
2.65
2019-11
0
1.93
2019-12
0
2.01
2020-01
0
2.83
2020-02
0
2.09
2020-03
0
2.25
2020-04
0
2.6
2020-05
0
1.96
2020-06
0
2.3
2020-07
0
3.12
2020-08
0
2.21
2020-09
0
2.25
2020-10
0
3.16
2020-11
0
2.26
2020-12
0
2.52
2021-01
0
2.46
2021-02
0
2.53
2021-03
0
2.36
2021-04
0
2.31
2021-05
0
2.7
2021-06
0
2.47
2021-07
0
2.26
2021-08
0
2.45
2021-09
0
2.27
2021-10
0
2.44
2021-11
0
2.13
2021-12
0
2.3
2022-01
0
2.17
2022-02
0
2.13
2022-03
0
1.99
2022-04
0
2.4
2022-05
0
1.87
2022-06
0
2.22
2022-07
0
2.07
2022-08
0
2.45
2022-09
0
2.22
2022-10
0
2.16
2022-11
0
2.11
2022-12
0
1.92
2023-01
0
1.81
2023-02
0
1.93
2023-03
0
2.05
2023-04
0
2.13
2023-05
0
1.87
2023-06
0
2.14
2023-07
0
2.21
2023-08
0
1.89
2023-09
0
1.91
2023-10
0
2.23
2023-11
0
2.39
2023-12
0
2.44
2024-01
0
1.78
2024-02
0
1.95
2024-03
2
1.81
2024-04
0
1.97
2024-05
0
1.94
2024-06
0
2.12
2024-07
0
1.98
2024-08
0
2.03
2024-09
0
2.09
2024-10
0
2.34
2024-11
0
2.52
2024-12
0
2.94
2025-01
0
2.92
2025-02
0
2.81
2025-03
0
2.59
2025-04
0
2.49
2025-05
0
2.65
2025-06
0
3.2
2025-07
0
3.28
2025-08
0
2.73
2025-09
0
2.89
2025-10
0
3.21
2025-11
0
3.14
2025-12
0
3.84
2026-01
0
3.43
2026-02
0
3.35
2026-03
0
3.22
2026-04
0
3.05
2026-05
0
3.34
2026-06
0
3.33
This device (reports/month)Average device in DQY, MJN (reports/device/month)
Failure-mode summaryAI-generated
2 linked report narratives available — no AI summary generated yet.