The same device (matched on an identical UDI-DI) is registered in other jurisdictions. EU coverage (EUDAMED) is still phasing in — absence here does not mean a device is not marketed there.
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.
13 linked reportsInjury 13
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
1
2019-05
0
1
2019-08
0
1.67
2019-10
0
1.17
2019-11
0
1.67
2019-12
0
1
2020-01
0
1
2020-03
0
1
2020-07
0
1
2020-08
0
1
2020-09
0
1
2020-11
0
1
2020-12
0
1
2021-06
0
1
2021-08
1
1
2021-09
0
1
2021-10
3
2.2
2021-11
3
2.5
2021-12
0
7
2022-01
3
2.25
2022-02
0
1.75
2022-03
0
2
2022-04
3
3
2022-05
0
1
2022-06
0
1.33
2022-09
0
1
2022-10
0
1
2022-11
0
1
2022-12
0
1.5
2023-01
0
2
2023-02
0
1
2023-03
0
1
2023-04
0
2
2023-05
0
1.5
2023-06
0
1.4
2023-07
0
1.8
2023-08
0
1.25
2023-09
0
1
2023-10
0
1.67
2023-11
0
1.33
2023-12
0
2
2024-01
0
1
2024-02
0
1
2024-03
0
1.14
2024-04
0
2
2024-06
0
1.25
2024-07
0
1
2024-08
0
1.67
2024-09
0
1.5
2024-10
0
1
2024-11
0
1
2024-12
0
1.25
2025-01
0
2.17
2025-02
0
2
2025-03
0
1.33
2025-04
0
2
2025-05
0
1
2025-06
0
1.75
2025-07
0
1.25
2025-08
0
1.5
2025-10
0
1.17
2025-11
0
1.67
2025-12
0
2
2026-01
0
3
2026-02
0
1.44
2026-03
0
2
2026-04
0
1.5
2026-05
0
1.33
2026-06
0
1.2
This device (reports/month)Average device in PKC (reports/device/month)
Failure-mode summaryAI-generated
13 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
Date
Report #
Type
Narrative
Link basis
2022-04-27
3009532798-2022-00108
Injury
Available
catalog number
2022-01-12
3009532798-2021-00254
Injury
Available
catalog number
2021-11-15
3009532798-2021-00172
Injury
Available
catalog number
2021-10-22
3009532798-2021-00160
Injury
Available
catalog number
2021-08-05
3009532798-2021-00112
Injury
Available
exact di
Showing the most recent 5 of 13 linked reports.
Regulatory clearances
510(k)K201391Substantially equivalent (SESE) · 2021-02-16clearance 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.