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 reportInjury 1
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-04
0
2
2019-05
0
1
2020-06
0
1
2020-07
0
1
2020-11
0
1
2021-01
0
1
2021-04
0
1.5
2021-05
0
1.5
2021-08
1
2.67
2021-09
0
1
2021-11
0
1
2022-01
0
2
2022-02
0
3
2022-03
0
1.25
2022-04
0
1
2022-05
0
2.88
2022-06
0
1
2022-07
0
3
2022-08
0
3.94
2022-09
0
1
2022-10
0
4.76
2022-11
0
18.35
2022-12
0
7.97
2023-01
0
16.17
2023-02
0
21.67
2023-03
0
19.63
2023-04
0
20.62
2023-05
0
19.31
2023-06
0
19.22
2023-07
0
28.53
2023-08
0
32.97
2023-09
0
16.09
2023-10
0
17.95
2023-11
0
7.7
2023-12
0
24.76
2024-01
0
13.79
2024-02
0
31.11
2024-03
0
72.77
2024-04
0
149.74
2024-05
0
170.89
2024-06
0
175.03
2024-07
0
149.34
2024-08
0
56.81
2024-09
0
48.08
2024-10
0
23.39
2024-11
0
18.62
2024-12
0
7.91
2025-01
0
1.11
2025-02
0
1.18
2025-03
0
2
2025-04
0
1.87
2025-05
0
1.75
2025-06
0
1.5
2025-07
0
1.08
2025-08
0
1.97
2025-09
0
1.09
2025-10
0
1.09
2025-11
0
2.25
2025-12
0
1.03
2026-01
0
1.03
2026-02
0
1.43
2026-03
0
1.18
2026-04
0
2
2026-05
0
1.28
2026-06
0
1.88
This device (reports/month)Average device in HMX (reports/device/month)
Failure-mode summaryAI-generated
1 linked report narrative available — no AI summary generated yet.