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 reportsMalfunction 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
9.29
2019-02
0
6.97
2019-03
0
6.36
2019-04
0
8.51
2019-05
0
6.28
2019-06
0
6.39
2019-07
0
7.28
2019-08
0
7.78
2019-09
0
7.37
2019-10
0
7.94
2019-11
0
7.27
2019-12
0
7.41
2020-01
0
6.59
2020-02
0
8.11
2020-03
0
7.62
2020-04
0
5.87
2020-05
0
5.71
2020-06
0
7.55
2020-07
0
9.13
2020-08
0
6.32
2020-09
0
7.36
2020-10
0
6.9
2020-11
0
6.9
2020-12
0
7.81
2021-01
0
6.49
2021-02
0
6.5
2021-03
0
7.26
2021-04
0
6.7
2021-05
0
6.37
2021-06
0
7.91
2021-07
0
7.03
2021-08
0
6.32
2021-09
0
6.79
2021-10
0
8.35
2021-11
0
7.67
2021-12
0
8.78
2022-01
0
6.92
2022-02
0
7.23
2022-03
0
8.02
2022-04
0
7.31
2022-05
0
6.91
2022-06
1
8.28
2022-07
0
6.13
2022-08
0
6.74
2022-09
0
7.56
2022-10
0
7.62
2022-11
0
8.12
2022-12
0
7.08
2023-01
0
8.29
2023-02
0
6.05
2023-03
0
6.49
2023-04
0
7.76
2023-05
0
6.88
2023-06
0
6.96
2023-07
0
6.87
2023-08
0
6.04
2023-09
0
6.62
2023-10
1
7.12
2023-11
0
5.83
2023-12
0
7.03
2024-01
0
7.27
2024-02
0
6.75
2024-03
0
6.82
2024-04
0
6.73
2024-05
0
6.73
2024-06
0
6.89
2024-07
0
5.69
2024-08
0
6.48
2024-09
1
6.56
2024-10
0
6.28
2024-11
0
6.15
2024-12
0
5.95
2025-01
0
6.56
2025-02
0
5.61
2025-03
0
6.63
2025-04
0
5.19
2025-05
0
6.98
2025-06
0
5.71
2025-07
0
6.78
2025-08
0
6.56
2025-09
0
6.07
2025-10
0
6.43
2025-11
0
6.1
2025-12
0
6.82
2026-01
0
6.97
2026-02
0
6.69
2026-03
0
6.52
2026-04
0
6.32
2026-05
0
7.42
2026-06
0
6.62
This device (reports/month)Average device in GEI, KNS, LFL (reports/device/month)
Failure-mode summaryAI-generated
3 linked report narratives available — no AI summary generated yet.