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)
2019-12
0
1
2020-01
0
1.67
2020-03
0
2
2020-05
0
4
2020-06
0
7
2020-07
0
11
2020-08
0
3.67
2020-09
0
5
2020-10
0
3.5
2020-11
0
7
2020-12
0
5
2021-01
0
6
2021-03
0
4
2021-04
0
9
2021-05
0
4
2021-06
0
5.5
2021-07
0
2
2021-08
0
1.5
2021-09
0
3
2021-10
0
6
2021-11
0
6
2021-12
0
2
2022-01
0
4
2022-02
0
6
2022-03
0
4.33
2022-04
0
8
2022-05
0
12
2022-06
0
4.5
2022-07
0
6
2022-09
0
3.5
2022-10
0
5
2022-11
0
3.67
2022-12
0
4
2023-01
0
2
2023-02
0
2
2023-03
0
5.5
2023-04
0
1
2023-05
0
1
2023-06
0
2
2023-07
0
2.75
2023-08
0
1
2023-09
0
5
2023-10
0
1.67
2023-12
0
6
2024-01
0
2
2024-02
0
1.5
2024-03
0
1.8
2024-05
0
4
2024-06
0
5.5
2024-07
0
2.67
2024-08
0
1
2024-09
0
4
2024-10
0
2
2024-11
0
2
2024-12
0
2
2025-06
0
1.5
2025-07
0
2.33
2025-08
0
1
2025-10
0
5
2025-11
0
2
2025-12
0
3
2026-01
0
8.83
2026-02
0
13.75
2026-03
0
15.14
2026-04
1
18.83
2026-05
0
7.67
2026-06
0
62.19
This device (reports/month)Average device in KQM (reports/device/month)
Failure-mode summaryAI-generated
1 linked report narrative available — no AI summary generated yet.