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.
4 linked reportsMalfunction 4
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
21.43
2019-02
0
18.76
2019-03
0
17.38
2019-04
0
19.33
2019-05
0
13.96
2019-06
2
13.78
2019-07
0
13.72
2019-08
0
17.95
2019-09
0
18.36
2019-10
0
18.02
2019-11
0
15.86
2019-12
0
17.13
2020-01
0
16.71
2020-02
0
20.62
2020-03
0
18.02
2020-04
0
17.91
2020-05
0
18.04
2020-06
0
23
2020-07
1
18.62
2020-08
0
16.63
2020-09
0
17.67
2020-10
0
14.94
2020-11
0
24.82
2020-12
0
22.21
2021-01
0
15.96
2021-02
0
16.49
2021-03
0
19.12
2021-04
0
15.19
2021-05
0
15.95
2021-06
0
19
2021-07
0
16.37
2021-08
0
18
2021-09
0
23.38
2021-10
0
22.3
2021-11
0
22.43
2021-12
0
30.38
2022-01
0
17.63
2022-02
0
20.54
2022-03
0
24.04
2022-04
0
20.64
2022-05
0
19.24
2022-06
0
25.56
2022-07
0
14.88
2022-08
0
22.97
2022-09
0
23.4
2022-10
0
24.15
2022-11
0
27.41
2022-12
0
24.35
2023-01
0
25.31
2023-02
0
18
2023-03
0
17.71
2023-04
1
24.73
2023-05
0
20.82
2023-06
0
21.58
2023-07
0
19.96
2023-08
0
18.26
2023-09
0
17.14
2023-10
0
20.16
2023-11
0
16.89
2023-12
0
23.32
2024-01
0
18.64
2024-02
0
16.59
2024-03
0
13.58
2024-04
0
14.97
2024-05
0
12.78
2024-06
0
18.13
2024-07
0
13.33
2024-08
0
15.55
2024-09
0
17.28
2024-10
0
12.35
2024-11
0
11.41
2024-12
0
16.73
2025-01
0
13.56
2025-02
0
13.63
2025-03
0
12.54
2025-04
0
11.36
2025-05
0
16.95
2025-06
0
13.06
2025-07
0
18
2025-08
0
17.47
2025-09
0
14.61
2025-10
0
11.11
2025-11
0
10.08
2025-12
0
16.79
2026-01
0
14.68
2026-02
0
15.06
2026-03
0
11.26
2026-04
0
12.27
2026-05
0
12.42
2026-06
0
16.46
This device (reports/month)Average device in LFL (reports/device/month)
Failure-mode summaryAI-generated
4 linked report narratives available — no AI summary generated yet.