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.
15 linked reportsMalfunction 15
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
2.2
2019-02
0
1.4
2019-03
0
1.5
2019-04
0
2.1
2019-05
0
1.57
2019-06
0
1.17
2019-07
0
1.64
2019-08
0
2.6
2019-09
0
2.2
2019-10
0
3
2019-11
0
2.43
2019-12
0
1.56
2020-01
0
1.25
2020-02
0
2
2020-03
0
2.25
2020-04
0
1.89
2020-05
0
3.5
2020-06
0
6.38
2020-07
0
4.25
2020-08
0
4
2020-09
0
4.91
2020-10
0
2.95
2020-11
0
12.5
2020-12
0
2.45
2021-01
0
2.2
2021-02
0
1.5
2021-03
1
2.64
2021-04
0
1.4
2021-05
0
2.22
2021-06
0
1.38
2021-07
0
2
2021-08
0
2.67
2021-09
0
3.23
2021-10
0
2.54
2021-11
0
3.29
2021-12
0
2.45
2022-01
0
2.83
2022-02
0
1.71
2022-03
0
3.18
2022-04
0
2.8
2022-05
0
2.67
2022-06
0
2.4
2022-07
0
2.86
2022-08
0
2.56
2022-09
0
2.14
2022-10
1
2.43
2022-11
0
1.9
2022-12
0
2.53
2023-01
0
2
2023-02
0
1.93
2023-03
0
3.13
2023-04
0
3.14
2023-05
0
2.25
2023-06
0
3.29
2023-07
0
2.57
2023-08
0
2.53
2023-09
0
2.38
2023-10
0
2.79
2023-11
0
2.3
2023-12
0
1.78
2024-01
0
1.42
2024-02
0
2.15
2024-03
0
2.08
2024-04
0
2.46
2024-05
0
1.36
2024-06
0
2.9
2024-07
0
1.75
2024-08
0
1.9
2024-09
0
3.07
2024-10
0
2.5
2024-11
0
5.33
2024-12
0
6.31
2025-01
0
2.14
2025-02
0
2
2025-03
3
3.07
2025-04
0
2.53
2025-05
0
7.53
2025-06
0
1.78
2025-07
0
3.12
2025-08
0
2
2025-09
4
3.27
2025-10
0
2.75
2025-11
0
2.56
2025-12
0
2
2026-01
0
1.75
2026-02
0
3.77
2026-03
0
3.09
2026-04
0
5.55
2026-05
6
4.93
2026-06
0
3.41
This device (reports/month)Average device in FDI (reports/device/month)
Failure-mode summaryAI-generated
15 linked report narratives available — no AI summary generated yet.