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
9.36
2019-02
0
8.88
2019-03
0
9.49
2019-04
0
10.01
2019-05
0
8.46
2019-06
0
10.21
2019-07
0
10.33
2019-08
0
8.63
2019-09
0
8.99
2019-10
0
8.74
2019-11
0
9.01
2019-12
0
9.67
2020-01
0
9.4
2020-02
0
8.78
2020-03
0
9.01
2020-04
0
7.88
2020-05
0
7.14
2020-06
0
9.22
2020-07
0
9.92
2020-08
0
9.35
2020-09
0
10.44
2020-10
0
10.3
2020-11
0
10.08
2020-12
0
10.95
2021-01
0
9.22
2021-02
0
9.19
2021-03
0
9.11
2021-04
0
10.6
2021-05
0
9.9
2021-06
0
9.43
2021-07
0
9.5
2021-08
0
12.2
2021-09
0
10.61
2021-10
0
10.32
2021-11
0
8.7
2021-12
0
10.82
2022-01
0
9.06
2022-02
0
8.84
2022-03
0
9.68
2022-04
0
9.6
2022-05
0
9.65
2022-06
0
10.47
2022-07
0
9.51
2022-08
0
10.42
2022-09
0
9.36
2022-10
0
10.04
2022-11
0
10.38
2022-12
0
10.31
2023-01
0
9.43
2023-02
0
9.77
2023-03
0
12.51
2023-04
0
9.56
2023-05
0
9.58
2023-06
0
10.77
2023-07
0
10.57
2023-08
0
8.38
2023-09
0
8.01
2023-10
0
8.45
2023-11
0
8.16
2023-12
0
9.19
2024-01
0
9.46
2024-02
0
9.67
2024-03
0
7.73
2024-04
0
8.71
2024-05
0
7.33
2024-06
0
8.41
2024-07
0
8.49
2024-08
0
7.57
2024-09
0
10.03
2024-10
0
8.44
2024-11
0
9.75
2024-12
0
7.51
2025-01
0
8.71
2025-02
0
7.44
2025-03
0
7.21
2025-04
0
6.84
2025-05
0
8.99
2025-06
1
8.25
2025-07
0
10.73
2025-08
0
8.82
2025-09
0
8.96
2025-10
0
8.35
2025-11
0
8.75
2025-12
0
10.1
2026-01
0
9.39
2026-02
0
9.23
2026-03
0
9.43
2026-04
0
9.18
2026-05
0
7.91
2026-06
0
10.11
This device (reports/month)Average device in GDW (reports/device/month)
Failure-mode summaryAI-generated
1 linked report narrative available — no AI summary generated yet.