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
2.26
2019-02
0
1.84
2019-03
0
1.66
2019-04
0
2.15
2019-05
0
1.88
2019-06
0
1.99
2019-07
0
2.54
2019-08
0
2.21
2019-09
0
2.12
2019-10
0
2.78
2019-11
0
1.93
2019-12
0
2.06
2020-01
0
2.77
2020-02
0
2.25
2020-03
0
2.3
2020-04
0
2.86
2020-05
0
2.25
2020-06
0
2.34
2020-07
0
3.08
2020-08
0
2.33
2020-09
0
2.28
2020-10
0
3.12
2020-11
0
2.13
2020-12
0
2.52
2021-01
0
2.38
2021-02
0
2.66
2021-03
0
2.64
2021-04
0
2.71
2021-05
0
2.62
2021-06
0
2.63
2021-07
0
2.8
2021-08
0
2.47
2021-09
0
2.49
2021-10
0
2.59
2021-11
0
2.56
2021-12
0
2.41
2022-01
0
2.53
2022-02
0
2.58
2022-03
0
2.79
2022-04
0
2.35
2022-05
0
2.5
2022-06
0
2.39
2022-07
0
2.4
2022-08
0
2.47
2022-09
0
2.17
2022-10
0
2.38
2022-11
0
2.2
2022-12
0
2.48
2023-01
0
2.54
2023-02
0
2.26
2023-03
0
2.6
2023-04
0
2.39
2023-05
0
2.05
2023-06
0
2.41
2023-07
0
2.41
2023-08
0
1.88
2023-09
0
1.77
2023-10
0
2.06
2023-11
0
1.98
2023-12
0
1.73
2024-01
0
1.94
2024-02
0
1.87
2024-03
0
1.86
2024-04
0
2.08
2024-05
0
2
2024-06
0
1.98
2024-07
0
2.12
2024-08
0
1.98
2024-09
0
2.14
2024-10
0
2.45
2024-11
0
3.01
2024-12
0
2.73
2025-01
0
3.03
2025-02
0
3.27
2025-03
0
3.02
2025-04
0
2.95
2025-05
3
3.05
2025-06
0
3.17
2025-07
0
3.01
2025-08
0
3.39
2025-09
0
3.03
2025-10
0
2.84
2025-11
0
3.42
2025-12
0
3.86
2026-01
0
3.56
2026-02
0
3.73
2026-03
0
3.35
2026-04
0
3.59
2026-05
0
3.18
2026-06
0
3.73
This device (reports/month)Average device in LIT (reports/device/month)
Failure-mode summaryAI-generated
3 linked report narratives available — no AI summary generated yet.