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.
38 linked reportsMalfunction 31Injury 7
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
4.67
2019-02
0
2.34
2019-03
0
3.13
2019-04
0
3.17
2019-05
0
3.26
2019-06
0
2.82
2019-07
0
3.81
2019-08
0
3.49
2019-09
0
3.35
2019-10
0
3.19
2019-11
0
5.28
2019-12
0
5.45
2020-01
0
5.46
2020-02
0
4.5
2020-03
1
3.98
2020-04
0
5.42
2020-05
0
3.88
2020-06
1
3.71
2020-07
0
3.74
2020-08
0
4.23
2020-09
0
4.05
2020-10
0
4.53
2020-11
0
6.39
2020-12
0
5.41
2021-01
0
4.74
2021-02
0
3.95
2021-03
0
3.83
2021-04
0
3.82
2021-05
0
4.06
2021-06
0
4.11
2021-07
0
4
2021-08
0
4.46
2021-09
1
4.05
2021-10
0
4.44
2021-11
0
4.37
2021-12
1
4.43
2022-01
0
4
2022-02
0
3.37
2022-03
0
3.88
2022-04
0
3.8
2022-05
0
4.06
2022-06
0
3.85
2022-07
1
3.56
2022-08
0
4.39
2022-09
0
3.86
2022-10
0
4.15
2022-11
1
2.87
2022-12
0
3.93
2023-01
0
3.27
2023-02
2
3.2
2023-03
4
3.8
2023-04
3
4.26
2023-05
4
4.67
2023-06
0
4.2
2023-07
0
3.85
2023-08
0
4.49
2023-09
2
4.47
2023-10
4
4.71
2023-11
0
4.63
2023-12
1
5.49
2024-01
1
5.56
2024-02
0
4.93
2024-03
0
4.78
2024-04
1
5.43
2024-05
0
6.48
2024-06
0
7.52
2024-07
0
4.11
2024-08
0
4.21
2024-09
1
5
2024-10
0
4.7
2024-11
3
4.41
2024-12
0
4.25
2025-01
0
5.12
2025-02
0
4.81
2025-03
0
4.57
2025-04
0
4.98
2025-05
0
5.81
2025-06
0
5.47
2025-07
1
5.19
2025-08
1
5.08
2025-09
1
4.29
2025-10
0
4.62
2025-11
0
5.25
2025-12
0
6.07
2026-01
1
5.06
2026-02
0
5.39
2026-03
0
5.98
2026-04
1
5.93
2026-05
0
5.88
2026-06
1
6.16
This device (reports/month)Average device in MBI (reports/device/month)
Failure-mode summaryAI-generated
38 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
Date
Report #
Type
Narrative
Link basis
2026-06-01
0001825034-2026-01519
Malfunction
Available
exact di
2026-04-08
0001825034-2026-00867
Malfunction
Available
exact di
2026-01-27
0001825034-2026-00228
Malfunction
Available
exact di
2025-09-15
0001825034-2025-02910
Malfunction
Available
exact di
2025-08-06
0001825034-2025-02382
Malfunction
Available
exact di
2025-07-16
0001825034-2025-02127
Malfunction
Available
exact di
2024-11-18
0001825034-2024-02701
Malfunction
Available
exact di
2024-11-13
0001825034-2024-02672
Malfunction
Available
exact di
2024-11-12
0001825034-2024-02663
Injury
Available
exact di
2024-09-17
0001825034-2024-02206
Malfunction
Available
exact di
2024-04-18
0001825034-2024-01051
Malfunction
Available
exact di
2024-01-24
0001825034-2024-00132
Malfunction
Available
exact di
2023-12-28
0001825034-2023-03075
Injury
Available
exact di
2023-10-31
0001825034-2023-02541
Injury
Available
exact di
2023-10-25
0001825034-2023-02461
Malfunction
Available
exact di
Showing 1–15 of 38
Regulatory clearances
510(k)K191459Substantially equivalent (SESE) · 2019-09-13clearance family
510(k)K150424Substantially equivalent (SESE) · 2015-05-15clearance 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.