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.
4 linked reportsInjury 4
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
2
2019-03
0
4
2019-04
0
1
2019-05
0
1
2019-06
0
1
2019-07
0
1
2019-10
0
1
2020-03
0
1
2020-04
0
1
2020-07
0
1
2020-10
0
1
2020-11
0
1
2021-01
0
1
2021-04
0
1
2021-07
0
1
2021-10
0
2
2022-01
0
2
2022-02
0
1
2022-03
0
1
2022-07
0
1
2022-08
0
1
2022-10
0
1
2023-01
0
1.5
2023-04
0
1
2023-10
0
1
2023-11
0
1
2024-01
0
5
2024-04
0
1
2024-05
0
1
2024-06
0
1
2024-07
0
1
2024-08
0
1
2024-09
0
1
2024-10
0
1
2024-11
0
1
2025-01
0
1
2025-02
0
1
2025-03
0
1
2025-04
0
1
2025-07
0
1
2025-10
0
1
2026-01
0
1
2026-02
0
1
2026-03
0
2
2026-04
0
1
2026-05
4
2
2026-06
0
1.5
This device (reports/month)Average device in OAR (reports/device/month)
Failure-mode summaryAI-generated
4 linked report narratives available — no AI summary generated yet.