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)
2019-07
0
1
2019-08
0
1
2019-09
0
1
2019-10
0
2
2020-02
0
1
2020-03
0
1
2020-08
0
1
2020-10
0
1
2020-12
0
1
2021-06
0
1
2021-08
0
2
2021-09
0
1.5
2021-11
0
1
2021-12
0
1
2022-01
0
1
2022-03
0
1
2022-04
0
1
2022-06
1
1
2022-07
0
1
2022-08
0
1
2022-09
0
1
2022-10
0
1
2022-11
0
4
2022-12
0
3
2023-01
0
1
2023-03
0
1
2023-04
0
1
2023-06
0
1.5
2023-07
0
2
2023-11
0
1
2023-12
0
1
2024-01
0
2
2024-02
0
1.5
2024-03
0
1.5
2024-04
0
1
2024-06
0
1.5
2024-07
0
3
2024-08
0
5
2024-09
0
2.5
2024-10
0
2.5
2024-11
0
16
2024-12
0
12.5
2025-01
0
21
2025-02
0
19
2025-03
0
19
2025-04
0
21
2025-05
0
12
2025-06
0
18.5
2025-07
0
13
2025-08
0
17
2025-09
0
8
2025-10
0
6.5
2025-11
0
7
2025-12
0
12
2026-01
0
6
2026-02
0
4.67
2026-03
0
9.5
2026-04
0
5
2026-05
0
8
2026-06
0
3.6
This device (reports/month)Average device in FMZ (reports/device/month)
Failure-mode summaryAI-generated
1 linked report narrative available — no AI summary generated yet.