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.
34 linked reportsInjury 33Malfunction 1
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-02
0
1
2019-05
0
1.5
2019-07
0
1
2019-08
0
1.8
2019-12
0
1
2020-02
0
5
2020-06
0
2
2020-07
0
1.5
2020-08
0
6
2020-09
0
1.5
2020-10
0
2.5
2020-11
0
3.4
2020-12
0
1
2021-01
0
1
2021-02
0
2
2021-03
0
1.33
2021-04
0
2
2021-05
0
2
2021-06
0
2
2021-08
0
1
2021-09
0
1
2021-10
0
3
2021-11
0
1
2021-12
0
1
2022-01
0
1
2022-02
0
1
2022-03
0
1
2022-04
0
1
2022-05
0
5
2022-06
4
2.5
2022-07
4
4
2022-08
0
3
2022-09
2
1.75
2022-10
3
2.38
2022-11
0
2
2022-12
1
1.14
2023-01
2
1.57
2023-02
0
3.33
2023-03
1
1.71
2023-04
1
1
2023-05
0
1.33
2023-06
1
1.78
2023-07
3
2.24
2023-08
1
1.57
2023-09
1
6.07
2023-10
0
1.86
2023-11
1
1.65
2023-12
0
1.67
2024-01
1
1.6
2024-02
0
1.71
2024-03
0
1.83
2024-04
2
2.6
2024-05
0
2.5
2024-06
0
2.55
2024-07
0
2.57
2024-08
0
8.67
2024-09
0
2
2024-10
1
2
2024-11
1
1.4
2024-12
0
1.63
2025-01
0
3.55
2025-02
0
1.86
2025-03
0
1.82
2025-04
1
1.57
2025-05
2
1.67
2025-06
0
2.44
2025-07
0
1.86
2025-08
1
1.36
2025-09
0
2.86
2025-10
0
1.8
2025-11
0
2.25
2025-12
0
2.5
2026-01
0
2
2026-02
0
1.33
2026-03
0
3.67
2026-04
0
3.33
2026-05
0
2
2026-06
0
2
This device (reports/month)Average device in FTD, GDI, OUP (reports/device/month)
Failure-mode summaryAI-generated
34 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
Date
Report #
Type
Narrative
Link basis
2025-08-22
3020889437-2025-00004
Injury
Available
exact di
2025-05-19
3020889437-2025-00003
Injury
Available
exact di
2025-05-19
3020889437-2025-00002
Injury
Available
exact di
2025-04-22
3020889437-2025-00001
Injury
Available
exact di
2024-11-20
3020889437-2024-00006
Injury
Available
exact di
2024-10-24
3020889437-2024-00005
Malfunction
Available
exact di
2024-04-22
3020889437-2024-00003
Injury
Available
exact di
2024-04-01
3020889437-2024-00002
Injury
Available
exact di
2024-01-16
3020889437-2024-00001
Injury
Available
exact di
2023-11-29
3020889437-2023-00010
Injury
Available
exact di
2023-09-28
3020889437-2023-00009
Injury
Available
exact di
2023-08-11
3020889437-2023-00008
Injury
Available
exact di
2023-07-11
3020889437-2023-00006
Injury
Available
exact di
2023-07-11
3020889437-2023-00005
Injury
Available
exact di
2023-07-11
3020889437-2023-00007
Injury
Available
exact di
Showing the most recent 29 of 34 linked reports.
Showing 1–15 of 29
Regulatory clearances
510(k)K232153Substantially equivalent (SESE) · 2023-08-18clearance family
510(k)K221336Substantially equivalent (SESE) · 2022-08-05clearance family
510(k)K212399Substantially equivalent (SESE) · 2021-10-22clearance 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.