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.
7 linked reportsInjury 4Malfunction 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
1.42
2019-02
0
1.95
2019-03
0
1.69
2019-04
0
1.65
2019-05
0
2.3
2019-06
0
1.42
2019-07
0
1.54
2019-08
0
1.4
2019-09
0
1.5
2019-10
0
2.57
2019-11
0
1.7
2019-12
0
1.85
2020-01
0
1.76
2020-02
0
1.57
2020-03
0
1.63
2020-04
0
1.63
2020-05
0
1.39
2020-06
0
1.68
2020-07
0
1.8
2020-08
0
1.87
2020-09
0
1.64
2020-10
0
1.89
2020-11
0
1.76
2020-12
0
1.67
2021-01
0
1.55
2021-02
0
2.15
2021-03
0
1.9
2021-04
0
1.9
2021-05
0
1.79
2021-06
0
2
2021-07
0
2.08
2021-08
0
1.61
2021-09
0
2.13
2021-10
0
1.77
2021-11
0
1.62
2021-12
0
1.83
2022-01
0
1.52
2022-02
0
1.75
2022-03
0
2.05
2022-04
0
1.56
2022-05
0
1.28
2022-06
0
1.82
2022-07
1
2.66
2022-08
0
1.65
2022-09
0
1.64
2022-10
0
2.93
2022-11
0
1.49
2022-12
0
1.92
2023-01
0
2.32
2023-02
0
2.02
2023-03
0
2.17
2023-04
0
1.99
2023-05
0
1.84
2023-06
0
1.6
2023-07
0
1.92
2023-08
0
1.73
2023-09
0
1.34
2023-10
0
1.52
2023-11
0
2.24
2023-12
0
1.51
2024-01
0
1.88
2024-02
0
2.09
2024-03
0
1.65
2024-04
0
1.51
2024-05
0
1.85
2024-06
0
1.91
2024-07
0
1.76
2024-08
0
1.58
2024-09
0
1.56
2024-10
3
1.85
2024-11
0
1.98
2024-12
0
1.62
2025-01
0
1.57
2025-02
0
1.44
2025-03
0
1.52
2025-04
0
1.51
2025-05
0
1.74
2025-06
0
1.79
2025-07
0
1.78
2025-08
0
1.47
2025-09
0
1.43
2025-10
0
2.44
2025-11
0
2.85
2025-12
0
2.03
2026-01
0
1.92
2026-02
0
2.13
2026-03
3
1.69
2026-04
0
1.89
2026-05
0
1.71
2026-06
0
1.85
This device (reports/month)Average device in HWT (reports/device/month)
Failure-mode summaryAI-generated
7 linked report narratives available — no AI summary generated yet.