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 reportsInjury 2Malfunction 1
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
1.81
2019-02
0
1.75
2019-03
0
1.68
2019-04
0
1.92
2019-05
0
2.1
2019-06
0
1.86
2019-07
0
1.67
2019-08
0
2.15
2019-09
0
1.67
2019-10
0
1.89
2019-11
0
1.61
2019-12
0
1.79
2020-01
0
1.88
2020-02
0
2.01
2020-03
0
2.1
2020-04
0
1.67
2020-05
0
1.68
2020-06
0
1.99
2020-07
0
2.2
2020-08
0
1.82
2020-09
0
2
2020-10
0
2.22
2020-11
0
1.92
2020-12
0
1.84
2021-01
0
2.1
2021-02
0
1.86
2021-03
0
2.02
2021-04
0
2
2021-05
0
1.85
2021-06
0
1.81
2021-07
0
2.04
2021-08
0
2.22
2021-09
0
1.87
2021-10
0
2.15
2021-11
0
2.04
2021-12
0
2.43
2022-01
0
2.51
2022-02
0
2.33
2022-03
0
2.33
2022-04
0
2.35
2022-05
0
1.98
2022-06
0
2.23
2022-07
0
2.14
2022-08
0
2.16
2022-09
0
1.97
2022-10
0
1.92
2022-11
0
2.09
2022-12
0
1.98
2023-01
1
1.78
2023-02
0
1.9
2023-03
0
1.89
2023-04
1
2.11
2023-05
0
1.97
2023-06
0
2.14
2023-07
0
2.01
2023-08
0
1.67
2023-09
0
1.52
2023-10
0
1.57
2023-11
0
1.67
2023-12
0
1.41
2024-01
0
1.78
2024-02
0
1.89
2024-03
0
1.65
2024-04
0
1.81
2024-05
0
1.67
2024-06
0
1.83
2024-07
0
1.61
2024-08
0
1.66
2024-09
0
1.67
2024-10
0
1.68
2024-11
0
1.6
2024-12
0
1.63
2025-01
0
1.71
2025-02
0
1.62
2025-03
0
1.84
2025-04
0
1.73
2025-05
0
1.86
2025-06
0
1.89
2025-07
0
1.71
2025-08
0
1.64
2025-09
0
1.44
2025-10
0
1.6
2025-11
1
1.71
2025-12
0
2.19
2026-01
0
1.89
2026-02
0
1.71
2026-03
0
1.73
2026-04
0
1.72
2026-05
0
1.69
2026-06
0
1.69
This device (reports/month)Average device in KWS, KWT, MBF, PAO, PHX (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
2025-11-13
0001825034-2025-03600
Malfunction
Available
exact di
2023-04-20
0001825034-2023-00879
Injury
Available
exact di
2023-01-10
0001822565-2023-00051
Injury
Available
exact di
Regulatory clearances
510(k)K211729Substantially equivalent (SESE) · 2021-11-04clearance 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.