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.
2 linked reportsMalfunction 2
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
1
2019-04
0
1.5
2019-05
0
1
2019-06
0
1
2019-08
0
1
2019-09
0
1
2019-11
0
1
2020-02
0
3
2020-03
0
4
2020-05
0
2
2020-08
0
1
2020-10
0
1.5
2020-11
0
3
2020-12
0
2
2021-03
0
1.33
2021-04
0
2
2021-05
0
5.5
2021-07
0
2
2021-08
0
2
2021-09
0
3
2021-10
0
2
2021-11
0
2
2021-12
0
2
2022-04
0
2
2022-06
0
1
2022-08
0
3.67
2022-09
0
2.5
2022-10
0
1
2022-11
0
2
2023-01
0
2
2023-02
0
1
2023-03
0
3
2023-04
0
3
2023-05
0
2.5
2023-06
0
3
2023-07
0
1
2023-08
0
1
2023-09
0
2
2023-10
0
2.5
2023-11
2
1.67
2024-01
0
1
2024-02
0
4
2024-03
0
2
2024-04
0
2
2024-05
0
2
2024-06
0
1.5
2024-07
0
2
2024-09
0
1
2024-10
0
2
2024-11
0
1
2025-01
0
1.5
2025-02
0
2.83
2025-03
0
3.67
2025-04
0
2.67
2025-05
0
2.33
2025-06
0
1.8
2025-07
0
4
2025-08
0
4.5
2025-09
0
1.25
2025-10
0
1.33
2025-11
0
1.33
2025-12
0
2.56
2026-01
0
3.67
2026-02
0
2.83
2026-03
0
1.88
2026-04
0
4.6
2026-05
0
2.5
2026-06
0
1.4
This device (reports/month)Average device in GTZ, GWG (reports/device/month)
Failure-mode summaryAI-generated
2 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
Date
Report #
Type
Narrative
Link basis
2023-11-29
3015194982-2023-00008
Malfunction
Available
catalog number
Showing the most recent 1 of 2 linked reports.
Regulatory clearances
510(k)K191861Substantially equivalent (SESE) · 2019-12-06clearance family
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.