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.
3 linked reportsMalfunction 3
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
1
2019-03
0
2
2019-04
0
3.5
2019-07
0
1
2019-09
0
1.5
2019-12
0
1
2020-01
0
1.5
2020-02
0
1
2020-03
1
1
2020-04
0
1.67
2020-06
0
2
2020-08
1
1.67
2020-10
0
2.5
2020-12
0
2.36
2021-01
0
2.67
2021-02
0
1.5
2021-03
0
2
2021-04
0
2
2021-05
0
1.29
2021-06
0
1
2021-07
0
2
2021-08
0
1.5
2021-09
0
1
2021-10
0
2
2021-12
0
1
2022-02
0
3
2022-03
0
2
2022-04
1
1.33
2022-05
0
1.57
2022-06
0
1.38
2022-07
0
6
2022-09
0
1
2022-11
0
3.5
2022-12
0
2
2023-01
0
2
2023-02
0
1.5
2023-03
0
3
2023-04
0
1.45
2023-05
0
2
2023-06
0
4.5
2023-07
0
3
2023-09
0
3
2023-10
0
2
2023-11
0
3
2023-12
0
2.5
2024-03
0
2
2024-04
0
1
2024-05
0
2
2024-06
0
1
2024-07
0
1.25
2024-08
0
1
2025-01
0
1
2025-03
0
2
2025-04
0
1
2025-05
0
1
2025-07
0
1
2025-10
0
1
2025-11
0
1.33
2026-01
0
1
2026-02
0
1
2026-05
0
1.33
2026-06
0
1
This device (reports/month)Average device in IZL (reports/device/month)
Failure-mode summaryAI-generated
3 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
Date
Report #
Type
Narrative
Link basis
2022-04-29
3013677815-2022-00001
Malfunction
Available
procode brand trgm
2020-08-05
3013677815-2020-00002
Malfunction
Available
procode brand trgm
2020-03-09
3013677815-2020-00001
Malfunction
Available
procode brand trgm
Regulatory clearances
510(k)K251710Substantially equivalent (SESE) · 2025-10-24clearance family
510(k)K241980Substantially equivalent (SESE) · 2025-05-06clearance family
510(k)K170607Substantially equivalent (SESE) · 2017-07-17clearance 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.