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.
6 linked reportsMalfunction 6
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
12.61
2019-02
0
14.22
2019-03
0
13.85
2019-04
0
17.5
2019-05
0
19.56
2019-06
0
19.38
2019-07
0
13.25
2019-08
0
11.12
2019-09
0
11.48
2019-10
0
9.35
2019-11
0
11.54
2019-12
0
14.29
2020-01
0
10.73
2020-02
0
11.85
2020-03
0
12.83
2020-04
0
10.25
2020-05
0
15.28
2020-06
0
11.67
2020-07
0
13.94
2020-08
0
12.79
2020-09
0
11.96
2020-10
0
12.55
2020-11
0
13.4
2020-12
0
12.49
2021-01
0
11.56
2021-02
0
13.92
2021-03
0
13.11
2021-04
0
12.76
2021-05
0
14.7
2021-06
0
17.3
2021-07
0
13.51
2021-08
0
16.33
2021-09
0
22.49
2021-10
0
13.64
2021-11
0
16.05
2021-12
0
12.32
2022-01
0
9.85
2022-02
0
12.79
2022-03
0
14.48
2022-04
0
12.32
2022-05
0
16.09
2022-06
0
13.94
2022-07
0
12.26
2022-08
0
13.46
2022-09
0
13.6
2022-10
0
17.77
2022-11
0
15.05
2022-12
0
15.65
2023-01
0
13.08
2023-02
0
11.43
2023-03
0
15.05
2023-04
0
13.28
2023-05
0
15.78
2023-06
0
20.95
2023-07
0
23.27
2023-08
0
20.07
2023-09
0
15.46
2023-10
0
15.99
2023-11
0
15.46
2023-12
0
18.76
2024-01
0
23.68
2024-02
0
18.85
2024-03
0
19.43
2024-04
0
19.58
2024-05
0
16.49
2024-06
0
17.42
2024-07
0
20.3
2024-08
0
29.05
2024-09
0
19.61
2024-10
0
25.33
2024-11
0
13.95
2024-12
0
16.14
2025-01
1
15
2025-02
0
19.76
2025-03
0
23.53
2025-04
1
20.22
2025-05
0
20
2025-06
0
32.77
2025-07
1
17.84
2025-08
0
17.26
2025-09
0
19.04
2025-10
1
17.59
2025-11
0
16.49
2025-12
0
14.61
2026-01
1
15.04
2026-02
0
13.55
2026-03
0
14.82
2026-04
1
10.49
2026-05
0
11.19
2026-06
0
8.73
This device (reports/month)Average device in HAW, PGW (reports/device/month)
Failure-mode summaryAI-generated
6 linked report narratives available — no AI summary generated yet.