The same device (matched on an identical UDI-DI) is registered in other jurisdictions. EU coverage (EUDAMED) is still phasing in — absence here does not mean a device is not marketed there.
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.
199 linked reportsInjury 199
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
2.1
2019-02
0
2.32
2019-03
0
1.9
2019-04
0
2.37
2019-05
0
2.59
2019-06
1
1.9
2019-07
0
2.22
2019-08
0
2.61
2019-09
0
1.98
2019-10
0
2.02
2019-11
0
1.86
2019-12
1
1.81
2020-01
3
2.03
2020-02
4
1.99
2020-03
20
2.77
2020-04
2
1.94
2020-05
2
1.92
2020-06
1
2.12
2020-07
20
2.78
2020-08
5
1.9
2020-09
4
2.01
2020-10
3
2.32
2020-11
3
1.97
2020-12
4
1.94
2021-01
0
2.64
2021-02
3
2.25
2021-03
6
2.39
2021-04
6
2.35
2021-05
6
2.25
2021-06
2
2.32
2021-07
2
2.38
2021-08
2
2.45
2021-09
0
2.35
2021-10
1
2.85
2021-11
6
2.36
2021-12
19
3.62
2022-01
7
3.42
2022-02
6
2.83
2022-03
7
3.44
2022-04
0
3.11
2022-05
0
2.47
2022-06
3
2.58
2022-07
3
2.41
2022-08
0
2.61
2022-09
4
2.37
2022-10
0
2.45
2022-11
0
2.38
2022-12
0
2.59
2023-01
0
2.04
2023-02
0
2.27
2023-03
0
2.22
2023-04
9
2.56
2023-05
0
2.29
2023-06
3
2.39
2023-07
0
2.16
2023-08
0
1.92
2023-09
0
1.71
2023-10
5
1.74
2023-11
0
1.84
2023-12
1
1.52
2024-01
3
1.74
2024-02
0
2.03
2024-03
3
1.8
2024-04
2
1.99
2024-05
3
1.73
2024-06
0
1.88
2024-07
0
1.69
2024-08
0
1.77
2024-09
0
1.77
2024-10
1
1.9
2024-11
0
1.72
2024-12
1
1.71
2025-01
2
1.77
2025-02
0
1.77
2025-03
1
2.04
2025-04
1
1.87
2025-05
2
1.94
2025-06
0
2.13
2025-07
1
1.89
2025-08
0
1.73
2025-09
1
1.54
2025-10
1
1.77
2025-11
0
1.78
2025-12
1
2.29
2026-01
0
2.02
2026-02
0
1.93
2026-03
0
1.88
2026-04
0
1.78
2026-05
1
1.86
2026-06
1
1.95
This device (reports/month)Average device in 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
2026-06-12
3014128390-2026-00020
Injury
Available
exact di
2026-05-29
3014128390-2026-00019
Injury
Available
exact di
2025-12-12
3014128390-2025-00089
Injury
Available
exact di
2025-10-17
3014128390-2025-00072
Injury
Available
exact di
2025-09-04
3014128390-2025-00053
Injury
Available
exact di
2025-07-15
3014128390-2025-00042
Injury
Available
exact di
2025-05-15
3014128390-2025-00022
Injury
Available
exact di
2025-05-09
3014128390-2025-00021
Injury
Available
exact di
2025-04-30
3014128390-2025-00018
Injury
Available
exact di
2025-03-21
3014128390-2025-00012
Injury
Available
exact di
2025-01-29
3014128390-2025-00006
Injury
Available
exact di
2025-01-15
3014128390-2025-00002
Injury
Available
exact di
2024-12-05
3014128390-2024-00065
Injury
Available
exact di
2024-10-02
3014128390-2024-00050
Injury
Available
exact di
2024-05-27
3009532798-2024-00056
Injury
Available
exact di
Showing the most recent 147 of 199 linked reports.
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.