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.
3 linked reportsInjury 3
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
6.78
2019-02
0
4.31
2019-03
0
4.42
2019-04
0
6.06
2019-05
0
4.8
2019-06
0
5.02
2019-07
0
5.86
2019-08
0
6.1
2019-09
0
4.99
2019-10
0
5.76
2019-11
0
5.6
2019-12
0
5.37
2020-01
0
4.81
2020-02
0
5.52
2020-03
0
5.64
2020-04
0
3.57
2020-05
0
3.76
2020-06
0
5.11
2020-07
0
6.53
2020-08
0
4.64
2020-09
0
5.82
2020-10
0
5.5
2020-11
0
5.07
2020-12
0
5.27
2021-01
0
5.17
2021-02
0
4.89
2021-03
0
5.7
2021-04
0
5.26
2021-05
0
5.12
2021-06
0
5.77
2021-07
0
4.86
2021-08
0
4.3
2021-09
0
4.77
2021-10
0
6.17
2021-11
0
5.57
2021-12
0
5.56
2022-01
0
5.01
2022-02
0
5.15
2022-03
0
5.75
2022-04
0
4.98
2022-05
0
5.75
2022-06
0
6.28
2022-07
0
4.36
2022-08
0
4.59
2022-09
0
5
2022-10
0
4.74
2022-11
0
4.61
2022-12
0
4.02
2023-01
0
5.52
2023-02
0
4.57
2023-03
0
4.85
2023-04
0
4.73
2023-05
1
5.05
2023-06
0
4.78
2023-07
0
4.82
2023-08
0
4.4
2023-09
0
5.2
2023-10
0
5.1
2023-11
0
4.36
2023-12
0
4.77
2024-01
0
5.52
2024-02
0
5.44
2024-03
0
6.1
2024-04
0
5.99
2024-05
0
6.22
2024-06
0
5.32
2024-07
0
5.05
2024-08
0
4.99
2024-09
0
5.18
2024-10
0
5.66
2024-11
0
5.27
2024-12
0
4.04
2025-01
0
5.17
2025-02
0
4.43
2025-03
0
6.23
2025-04
0
4.38
2025-05
2
5.08
2025-06
0
5.03
2025-07
0
5.18
2025-08
0
5.41
2025-09
0
4.81
2025-10
0
5.12
2025-11
0
5.49
2025-12
0
5.77
2026-01
0
5.63
2026-02
0
5.92
2026-03
0
6.18
2026-04
0
5.36
2026-05
0
6.17
2026-06
0
5.52
This device (reports/month)Average device in GEI, GZJ, IPF, PBX (reports/device/month)
Failure-mode summaryAI-generated
3 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
Date
Report #
Type
Narrative
Link basis
2025-05-15
3010511300-2025-00817
Injury
Available
exact di
2025-05-15
3010511300-2025-00820
Injury
Available
exact di
2023-05-15
MW5117546
Injury
Available
model number
Regulatory clearances
510(k)K231495Substantially equivalent (SESE) · 2023-10-13clearance family
510(k)K210877Substantially equivalent (SESE) · 2021-07-19clearance 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.