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.
1 linked reportMalfunction 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
5.33
2019-02
0
7.85
2019-03
0
10.25
2019-04
0
5.8
2019-05
0
11.4
2019-06
0
8.8
2019-07
0
8.09
2019-08
0
14.5
2019-09
0
7.38
2019-10
0
5.07
2019-11
0
5.06
2019-12
0
6.59
2020-01
0
3.44
2020-02
0
7.45
2020-03
0
9.46
2020-04
0
9.07
2020-05
0
4.06
2020-06
0
3.67
2020-07
0
4.92
2020-08
0
3.48
2020-09
0
2.45
2020-10
0
3.7
2020-11
0
5.06
2020-12
0
7.46
2021-01
0
8.68
2021-02
0
4.93
2021-03
0
9.1
2021-04
0
5.52
2021-05
0
6.91
2021-06
0
8.75
2021-07
0
10.68
2021-08
0
8.63
2021-09
0
10.28
2021-10
1
6
2021-11
0
7.71
2021-12
0
11.19
2022-01
0
7.83
2022-02
0
8.56
2022-03
0
8.04
2022-04
0
8.92
2022-05
0
11.21
2022-06
0
8
2022-07
0
7.7
2022-08
0
5.72
2022-09
0
4.23
2022-10
0
4.36
2022-11
0
3.91
2022-12
0
5.16
2023-01
0
4.81
2023-02
0
4.14
2023-03
0
6.11
2023-04
0
3.44
2023-05
0
4.58
2023-06
0
3.76
2023-07
0
3.96
2023-08
0
5.61
2023-09
0
5.25
2023-10
0
7.6
2023-11
0
6
2023-12
0
5.56
2024-01
0
7.57
2024-02
0
4.38
2024-03
0
5.94
2024-04
0
5.62
2024-05
0
4.04
2024-06
0
5.71
2024-07
0
4.91
2024-08
0
5.59
2024-09
0
5.73
2024-10
0
6.81
2024-11
0
3.48
2024-12
0
12.43
2025-01
0
4.59
2025-02
0
3.9
2025-03
0
4.26
2025-04
0
3.22
2025-05
0
3.44
2025-06
0
3.97
2025-07
0
3.73
2025-08
0
5.65
2025-09
0
7.45
2025-10
0
9.14
2025-11
0
12.78
2025-12
0
20.42
2026-01
0
13.43
2026-02
0
6.53
2026-03
0
9.15
2026-04
0
12.83
2026-05
0
15.98
2026-06
0
14.81
This device (reports/month)Average device in IYO (reports/device/month)
Failure-mode summaryAI-generated
1 linked report narrative available — no AI summary generated yet.