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.
6 linked reportsMalfunction 6
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-05
0
2
2019-07
0
1
2019-12
0
1
2020-02
0
1
2020-03
0
1
2020-06
0
1
2020-09
0
1
2020-11
0
1.5
2020-12
0
2
2021-05
0
1
2021-07
0
2
2021-08
0
1.5
2021-09
0
1
2021-10
0
1
2021-11
0
2
2021-12
0
1
2022-02
0
1
2022-03
0
1
2022-06
0
1.43
2022-08
0
1
2022-09
0
1
2022-10
0
1
2022-11
0
1
2022-12
0
1
2023-01
0
1.4
2023-02
0
1
2023-03
0
1
2023-04
0
1
2023-05
0
1
2023-06
0
1
2023-08
0
1.5
2023-09
0
1
2023-10
0
1
2023-11
0
1.5
2023-12
0
2
2024-01
0
1
2024-03
0
1
2024-04
0
1.25
2024-05
0
1
2024-07
0
2
2024-08
1
1
2024-09
2
1.5
2024-10
0
1.5
2024-11
3
3
2024-12
0
1.5
2025-02
0
1
2025-03
0
2
2025-04
0
1
2025-05
0
2
2025-06
0
1.5
2025-07
0
1
2025-08
0
1.5
2025-09
0
2
2025-10
0
1.25
2025-11
0
1
2025-12
0
2
2026-02
0
1
2026-03
0
1
2026-04
0
1
2026-05
0
2
2026-06
0
1.29
This device (reports/month)Average device in IZQ (reports/device/month)
Failure-mode summaryAI-generated
6 linked report narratives available — no AI summary generated yet.
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.