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.
221 linked reportsInjury 221
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
1
1.98
2019-10
1
2.02
2019-11
0
1.86
2019-12
0
1.81
2020-01
3
2.03
2020-02
2
1.99
2020-03
12
2.77
2020-04
1
1.94
2020-05
1
1.92
2020-06
3
2.12
2020-07
8
2.78
2020-08
3
1.9
2020-09
1
2.01
2020-10
0
2.32
2020-11
1
1.97
2020-12
1
1.94
2021-01
0
2.64
2021-02
5
2.25
2021-03
1
2.39
2021-04
2
2.35
2021-05
0
2.25
2021-06
0
2.32
2021-07
0
2.38
2021-08
2
2.45
2021-09
2
2.35
2021-10
6
2.85
2021-11
0
2.36
2021-12
10
3.62
2022-01
6
3.42
2022-02
1
2.83
2022-03
39
3.44
2022-04
20
3.11
2022-05
0
2.47
2022-06
9
2.58
2022-07
0
2.41
2022-08
0
2.61
2022-09
0
2.37
2022-10
0
2.45
2022-11
0
2.38
2022-12
3
2.59
2023-01
6
2.04
2023-02
0
2.27
2023-03
3
2.22
2023-04
0
2.56
2023-05
6
2.29
2023-06
9
2.39
2023-07
11
2.16
2023-08
2
1.92
2023-09
0
1.71
2023-10
2
1.74
2023-11
4
1.84
2023-12
4
1.52
2024-01
0
1.74
2024-02
1
2.03
2024-03
0
1.8
2024-04
1
1.99
2024-05
1
1.73
2024-06
1
1.88
2024-07
1
1.69
2024-08
0
1.77
2024-09
1
1.77
2024-10
5
1.9
2024-11
2
1.72
2024-12
0
1.71
2025-01
1
1.77
2025-02
0
1.77
2025-03
0
2.04
2025-04
1
1.87
2025-05
0
1.94
2025-06
2
2.13
2025-07
1
1.89
2025-08
0
1.73
2025-09
0
1.54
2025-10
3
1.77
2025-11
1
1.78
2025-12
0
2.29
2026-01
1
2.02
2026-02
0
1.93
2026-03
0
1.88
2026-04
1
1.78
2026-05
1
1.86
2026-06
4
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
2026-06-29
3009532798-2026-00031
Injury
Available
exact di
2026-06-23
3009532798-2026-00027
Injury
Available
exact di
2026-06-15
3014128390-2026-00023
Injury
Available
exact di
2026-06-08
3009532798-2026-00025
Injury
Available
exact di
2026-05-12
3009532798-2026-00021
Injury
Available
exact di
2026-04-14
3014128390-2026-00009
Injury
Available
exact di
2026-01-23
3014128390-2026-00002
Injury
Available
exact di
2025-11-13
3009532798-2025-00066
Injury
Available
exact di
2025-10-17
3014128390-2025-00069
Injury
Available
exact di
2025-10-17
3009532798-2025-00061
Injury
Available
exact di
2025-10-16
3009532798-2025-00059
Injury
Available
exact di
2025-07-17
3014128390-2025-00045
Injury
Available
exact di
2025-06-19
3009532798-2025-00042
Injury
Available
exact di
2025-06-09
3009532798-2025-00037
Injury
Available
exact di
2025-04-22
3009532798-2025-00027
Injury
Available
exact di
Showing the most recent 128 of 221 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.