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
12.98
2019-02
0
17.85
2019-03
0
19.59
2019-04
0
26.01
2019-05
0
23.91
2019-06
0
21.7
2019-07
0
23.41
2019-08
0
20.36
2019-09
0
17.61
2019-10
0
19.02
2019-11
0
14.81
2019-12
0
17.44
2020-01
0
19.67
2020-02
0
16.38
2020-03
0
18.21
2020-04
0
16.13
2020-05
0
21.05
2020-06
0
26.64
2020-07
0
16.17
2020-08
0
11.09
2020-09
0
17.63
2020-10
0
11.3
2020-11
0
16.02
2020-12
0
16.67
2021-01
0
15.15
2021-02
0
15.62
2021-03
0
15.94
2021-04
0
15.99
2021-05
0
16.17
2021-06
0
17.06
2021-07
0
23.15
2021-08
0
15.47
2021-09
0
17.48
2021-10
0
16.01
2021-11
0
14.62
2021-12
0
19.25
2022-01
0
13.96
2022-02
0
13.11
2022-03
0
14.14
2022-04
0
13.67
2022-05
0
15.24
2022-06
0
12.22
2022-07
0
12.4
2022-08
0
7.51
2022-09
0
8.78
2022-10
0
7.55
2022-11
0
9.28
2022-12
0
6.72
2023-01
0
15.09
2023-02
0
8.24
2023-03
0
9.25
2023-04
0
7.25
2023-05
0
29.67
2023-06
0
20.39
2023-07
0
11.6
2023-08
0
10.31
2023-09
0
6.56
2023-10
0
5.81
2023-11
0
4.48
2023-12
0
4.12
2024-01
0
7.16
2024-02
0
2.86
2024-03
0
6.45
2024-04
0
4.13
2024-05
0
6.2
2024-06
0
4.59
2024-07
0
3.51
2024-08
0
3.31
2024-09
0
4.13
2024-10
0
4.28
2024-11
0
2.9
2024-12
0
4.81
2025-01
1
5
2025-02
0
2.73
2025-03
0
3.63
2025-04
0
4.11
2025-05
0
5.06
2025-06
0
3.11
2025-07
0
3.69
2025-08
0
4.25
2025-09
0
2.82
2025-10
0
3.54
2025-11
0
3.4
2025-12
0
2.57
2026-01
0
4.13
2026-02
0
2.39
2026-03
0
4.12
2026-04
0
3.52
2026-05
0
3.15
2026-06
0
4.11
This device (reports/month)Average device in CGA, NBW (reports/device/month)
Failure-mode summaryAI-generated
1 linked report narrative available — no AI summary generated yet.