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.
76 linked reportsInjury 55Malfunction 21
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
2.24
2019-02
0
2.08
2019-03
0
1.7
2019-04
0
2.05
2019-05
0
1.92
2019-06
0
2.17
2019-07
0
2.13
2019-08
0
2.43
2019-09
0
2.14
2019-10
0
2.69
2019-11
1
3.42
2019-12
1
2.57
2020-01
1
2.53
2020-02
0
2.7
2020-03
0
2.25
2020-04
0
2.13
2020-05
0
1.76
2020-06
0
2.05
2020-07
0
2.52
2020-08
1
2.53
2020-09
0
2.15
2020-10
1
2.78
2020-11
0
2.74
2020-12
0
2.78
2021-01
1
2.31
2021-02
1
2.34
2021-03
1
2.46
2021-04
0
2.33
2021-05
1
2.32
2021-06
2
2.15
2021-07
0
2.19
2021-08
1
1.88
2021-09
2
2.24
2021-10
0
1.92
2021-11
0
2.16
2021-12
0
2.24
2022-01
0
1.94
2022-02
0
2.22
2022-03
0
1.97
2022-04
1
2.03
2022-05
3
2.19
2022-06
0
1.94
2022-07
1
1.97
2022-08
0
2.02
2022-09
1
2.19
2022-10
4
2.05
2022-11
0
2.15
2022-12
0
1.81
2023-01
1
1.98
2023-02
0
2.13
2023-03
2
2.1
2023-04
6
2.13
2023-05
2
2.23
2023-06
1
2.11
2023-07
2
1.88
2023-08
2
1.63
2023-09
0
1.66
2023-10
3
1.54
2023-11
0
1.59
2023-12
1
1.64
2024-01
0
1.49
2024-02
0
1.67
2024-03
1
1.69
2024-04
4
1.57
2024-05
1
1.78
2024-06
2
1.85
2024-07
2
1.72
2024-08
0
2.15
2024-09
2
1.88
2024-10
3
1.88
2024-11
0
1.85
2024-12
2
1.91
2025-01
0
2.13
2025-02
1
1.72
2025-03
1
1.71
2025-04
0
1.57
2025-05
2
1.63
2025-06
1
1.68
2025-07
0
1.55
2025-08
2
1.54
2025-09
1
1.55
2025-10
1
1.37
2025-11
0
1.6
2025-12
2
1.62
2026-01
1
1.5
2026-02
1
1.46
2026-03
0
1.81
2026-04
1
1.64
2026-05
0
1.59
2026-06
1
1.59
This device (reports/month)Average device in JWH, OIY (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
2026-06-29
0001822565-2026-02291
Injury
Available
exact di
2026-04-16
0001822565-2026-01306
Injury
Available
exact di
2026-02-25
0001822565-2026-00618
Injury
Available
exact di
2026-01-30
0001822565-2026-00339
Injury
Available
exact di
2025-12-30
0001822565-2025-04918
Injury
Available
exact di
2025-12-15
0001822565-2025-04502
Injury
Available
exact di
2025-10-31
0001822565-2025-03937
Injury
Available
exact di
2025-09-06
0001822565-2025-03293
Malfunction
Available
exact di
2025-08-14
0001822565-2025-02933
Malfunction
Available
exact di
2025-08-14
0001822565-2025-02935
Malfunction
Available
exact di
2025-06-23
0001822565-2025-02069
Injury
Available
exact di
2025-05-29
0001822565-2025-01578
Injury
Available
exact di
2025-05-12
0001822565-2025-01350
Injury
Available
exact di
2025-03-17
0001822565-2025-00641
Injury
Available
exact di
2025-02-19
0001822565-2025-00408
Injury
Available
exact di
Showing 1–15 of 76
Regulatory clearances
510(k)K133737Substantially equivalent (SESE) · 2014-02-04clearance 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.