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.
15 linked reportsMalfunction 13Injury 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
4
2019-02
0
1.25
2019-03
0
1.8
2019-04
0
2
2019-05
0
1.75
2019-06
0
1.5
2019-07
2
2.24
2019-08
0
1.89
2019-09
0
2.38
2019-10
0
2.46
2019-11
0
4.11
2019-12
0
3
2020-01
0
3
2020-02
0
5
2020-03
0
2.85
2020-04
0
4.25
2020-05
0
2.5
2020-06
0
2.75
2020-07
0
2.38
2020-08
0
2.82
2020-09
0
3.14
2020-10
0
1.25
2020-11
0
5
2020-12
0
1.22
2021-01
0
1.8
2021-02
0
5
2021-03
0
2.38
2021-04
0
1.9
2021-05
0
2.13
2021-06
0
2.25
2021-07
0
2
2021-08
0
2.8
2021-09
0
1.86
2021-10
0
1.33
2021-11
0
3.33
2021-12
0
2.67
2022-01
0
2.36
2022-02
0
1.25
2022-03
0
2
2022-04
0
1.77
2022-05
0
1.75
2022-06
0
2
2022-07
0
2.1
2022-08
0
3.57
2022-09
0
2.11
2022-10
0
2.1
2022-11
0
2.4
2022-12
0
1.43
2023-01
0
2.14
2023-02
0
1.3
2023-03
1
2.38
2023-04
0
1.7
2023-05
1
1.25
2023-06
1
1.29
2023-07
1
1.57
2023-08
0
3.2
2023-09
0
1.71
2023-10
0
1.45
2023-11
0
3
2023-12
0
1
2024-01
0
1.25
2024-02
0
1.44
2024-03
0
1.43
2024-04
0
1
2024-05
0
1
2024-06
3
1.4
2024-07
0
1.4
2024-08
3
1.33
2024-09
0
1.67
2024-10
0
2.17
2024-11
0
2
2024-12
2
2.5
2025-01
0
1.43
2025-02
0
1.33
2025-03
0
1.3
2025-04
0
1.86
2025-05
0
1.64
2025-07
0
2
2025-08
0
1.67
2025-09
0
2.2
2025-10
0
1.33
2025-11
0
1.89
2025-12
0
3.17
2026-01
0
3
2026-02
1
3
2026-03
0
2.08
2026-04
0
2.57
2026-05
0
3.17
2026-06
0
2.71
This device (reports/month)Average device in GEH (reports/device/month)
Failure-mode summaryAI-generated
15 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
Date
Report #
Type
Narrative
Link basis
2026-02-13
1528319-2026-00013
Malfunction
Available
exact di
2024-12-20
1528319-2024-00110
Malfunction
Available
catalog number
2024-08-29
1528319-2024-00070
Malfunction
Available
catalog number
2024-06-11
1528319-2024-00046
Malfunction
Available
catalog number
2023-07-07
1528319-2023-00025
Malfunction
Available
exact di
2023-06-21
1528319-2023-00022
Malfunction
Available
exact di
2023-05-11
1528319-2023-00014
Malfunction
Available
exact di
2023-03-29
1528319-2023-00007
Malfunction
Available
exact di
2019-07-23
3010140265-2019-00002
Injury
Available
exact di
2019-07-23
3010140265-2019-00003
Injury
Available
exact di
Showing the most recent 10 of 15 linked reports.
Regulatory clearances
510(k)K223369Substantially equivalent (SESE) · 2022-12-02clearance family
510(k)K222272Substantially equivalent (SESE) · 2022-08-18clearance family
510(k)K171626Substantially equivalent (SESE) · 2017-08-30clearance 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.