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.
43 linked reportsInjury 32Malfunction 11
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
1.82
2019-02
0
1.85
2019-03
0
1.75
2019-04
0
1.88
2019-05
0
2.1
2019-06
0
1.88
2019-07
0
1.68
2019-08
0
2.18
2019-09
0
1.67
2019-10
1
1.88
2019-11
4
1.72
2019-12
1
1.77
2020-01
0
1.96
2020-02
0
2.08
2020-03
0
2.19
2020-04
1
1.8
2020-05
0
1.66
2020-06
0
1.95
2020-07
0
2.24
2020-08
0
1.76
2020-09
0
1.96
2020-10
1
2.2
2020-11
0
1.9
2020-12
0
1.87
2021-01
0
2.2
2021-02
1
1.99
2021-03
2
2.15
2021-04
1
2.02
2021-05
0
2.02
2021-06
0
1.91
2021-07
1
2.06
2021-08
0
2.19
2021-09
1
1.97
2021-10
2
2.18
2021-11
0
2.13
2021-12
0
2.6
2022-01
0
2.65
2022-02
1
2.35
2022-03
2
2.51
2022-04
0
2.48
2022-05
0
2.13
2022-06
0
2.24
2022-07
0
2.2
2022-08
1
2.27
2022-09
0
2.04
2022-10
0
2.12
2022-11
1
2.16
2022-12
0
2.1
2023-01
0
1.85
2023-02
1
2.06
2023-03
3
2.05
2023-04
0
2.22
2023-05
1
2.12
2023-06
2
2.32
2023-07
0
2.11
2023-08
1
1.76
2023-09
0
1.59
2023-10
0
1.64
2023-11
0
1.69
2023-12
0
1.46
2024-01
0
1.9
2024-02
0
1.89
2024-03
1
1.73
2024-04
1
1.87
2024-05
0
1.72
2024-06
1
1.89
2024-07
0
1.63
2024-08
0
1.73
2024-09
1
1.74
2024-10
0
1.73
2024-11
0
1.64
2024-12
0
1.67
2025-01
0
1.74
2025-02
0
1.65
2025-03
1
1.94
2025-04
0
1.73
2025-05
2
1.83
2025-06
0
1.96
2025-07
0
1.8
2025-08
1
1.61
2025-09
1
1.52
2025-10
1
1.69
2025-11
2
1.74
2025-12
0
2.19
2026-01
1
1.93
2026-02
0
1.85
2026-03
1
1.8
2026-04
0
1.74
2026-05
0
1.8
2026-06
0
1.8
This device (reports/month)Average device in KWS, PHX (reports/device/month)
Failure-mode summaryAI-generated
40 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
Date
Report #
Type
Narrative
Link basis
2026-03-25
0001825034-2026-00726
Injury
Available
exact di
2026-01-14
0001825034-2026-00139
Injury
Available
exact di
2025-11-26
0001825034-2025-03812
Injury
Available
exact di
2025-11-17
0001825034-2025-03664
Injury
Available
exact di
2025-10-29
0001825034-2025-03396
Injury
Available
exact di
2025-09-19
0001825034-2025-02955
Injury
Available
exact di
2025-08-08
0001825034-2025-02398
Injury
Available
exact di
2025-05-19
0001825034-2025-01450
Injury
Available
exact di
2025-05-05
0001825034-2025-01317
Injury
Available
exact di
2025-03-14
0001825034-2025-00726
Injury
Available
exact di
2024-09-18
0001825034-2024-02228
Injury
Available
exact di
2024-06-11
0001825034-2024-01539
Injury
Available
exact di
2024-04-03
0001825034-2024-00935
Injury
Available
exact di
2024-03-04
0001825034-2024-00608
Malfunction
Available
exact di
2023-08-29
0001825034-2023-02029
Injury
Available
exact di
Showing 1–15 of 43
Regulatory clearances
510(k)K113069Substantially equivalent (SESE) · 2012-01-11clearance 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.