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 reportsMalfunction 4Injury 1
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
2.92
2019-02
1
3.83
2019-03
0
3.38
2019-04
0
3.19
2019-05
0
4
2019-06
0
3.22
2019-07
0
3.63
2019-08
0
4.08
2019-09
0
4.22
2019-10
1
3.43
2019-11
0
3.02
2019-12
0
2.8
2020-01
0
3.15
2020-02
0
3.53
2020-03
0
2.95
2020-04
0
3.45
2020-05
0
3.28
2020-06
0
2.64
2020-07
0
3.24
2020-08
0
3.24
2020-09
0
4.05
2020-10
1
3.82
2020-11
0
3.28
2020-12
0
3.2
2021-01
0
2.43
2021-02
1
3.32
2021-03
0
2.96
2021-04
0
3.05
2021-05
1
2.16
2021-06
0
2.31
2021-07
0
3.09
2021-08
0
3.13
2021-09
0
3.57
2021-10
0
2.55
2021-11
0
2.37
2021-12
0
2.31
2022-01
0
2.27
2022-02
0
2.81
2022-03
0
2.62
2022-04
0
2.31
2022-05
0
2.47
2022-06
0
2.58
2022-07
0
2.56
2022-08
0
2.65
2022-09
0
2.55
2022-10
0
2.69
2022-11
0
4.2
2022-12
0
3.19
2023-01
0
4.29
2023-02
0
4.73
2023-03
0
5.6
2023-04
0
4.98
2023-05
0
5
2023-06
0
5.14
2023-07
0
6.02
2023-08
0
5.7
2023-09
0
5.14
2023-10
0
4.48
2023-11
0
3.85
2023-12
0
5.61
2024-01
0
4.24
2024-02
0
7.28
2024-03
0
8.65
2024-04
0
13.36
2024-05
0
17.87
2024-06
0
16.58
2024-07
0
13.72
2024-08
0
9.31
2024-09
0
7.24
2024-10
0
5.47
2024-11
0
3.94
2024-12
0
4.21
2025-01
0
2.94
2025-02
0
2.37
2025-03
0
2.97
2025-04
0
3.33
2025-05
0
2.84
2025-06
0
4.16
2025-07
0
2.88
2025-08
0
2.85
2025-09
0
2.66
2025-10
0
3.28
2025-11
0
3.18
2025-12
0
2.47
2026-01
0
2.95
2026-02
0
3.78
2026-03
0
2.97
2026-04
0
2.86
2026-05
0
2.87
2026-06
0
3.59
This device (reports/month)Average device in FMF (reports/device/month)
Failure-mode summaryAI-generated
5 linked report narratives available — no AI summary generated yet.