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.
23 linked reportsMalfunction 20Injury 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
2.83
2019-02
0
3
2019-03
0
4
2019-04
0
2.45
2019-05
0
22
2019-06
0
4.25
2019-07
0
4.33
2019-08
0
7
2019-09
0
1.8
2019-10
0
1.6
2019-11
0
1.25
2019-12
0
2.33
2020-01
0
1.4
2020-02
0
2.38
2020-03
0
4
2020-04
0
1.67
2020-05
0
1.5
2020-06
0
2.5
2020-07
0
3
2020-08
0
4.33
2020-09
0
1.2
2020-10
0
6
2020-11
0
1.71
2020-12
0
3.67
2021-01
0
3
2021-02
0
3
2021-03
0
6
2021-04
0
5.33
2021-05
0
7.67
2021-06
0
5
2021-07
0
4.8
2021-08
3
3.58
2021-09
0
2.86
2021-10
3
3
2021-11
0
3
2021-12
0
2.83
2022-01
0
2.29
2022-02
0
3.5
2022-03
6
4.71
2022-04
0
3
2022-05
0
4.5
2022-06
3
2.92
2022-07
0
3.6
2022-08
0
2.67
2022-09
0
2.09
2022-10
0
2.8
2022-11
0
6.09
2022-12
0
1.5
2023-01
0
4.83
2023-02
0
2.7
2023-03
0
2.62
2023-04
0
3.44
2023-05
0
4.5
2023-06
6
3.5
2023-07
0
3.5
2023-08
0
3.14
2023-09
0
2.89
2023-10
0
2.5
2023-11
0
2.84
2023-12
0
3.9
2024-01
0
1.82
2024-02
0
2.67
2024-03
0
2.85
2024-04
2
3.64
2024-05
0
5.13
2024-06
0
2
2024-07
0
2.53
2024-08
0
5.5
2024-09
0
2.15
2024-10
0
3.85
2024-11
0
4.83
2024-12
0
3.86
2025-01
0
1.71
2025-02
0
4.05
2025-03
0
3.56
2025-04
0
2.07
2025-05
0
3
2025-06
0
4.2
2025-07
0
1.75
2025-08
0
4
2025-09
0
2
2025-10
0
2.17
2025-11
0
2.6
2025-12
0
1.77
2026-01
0
1.92
2026-02
0
2
2026-03
0
5
2026-04
0
1.36
2026-05
0
2.33
2026-06
0
1.67
This device (reports/month)Average device in LRC, PGW, PNZ (reports/device/month)
Failure-mode summaryAI-generated
23 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
Date
Report #
Type
Narrative
Link basis
2024-04-24
3005172759-2024-00031
Malfunction
Available
catalog number
2023-06-26
3005172759-2023-00037
Malfunction
Available
catalog number
2023-06-07
3005172759-2023-00034
Injury
Available
catalog number
2022-06-03
3005172759-2022-00008
Malfunction
Available
catalog number
2022-03-21
3005172759-2022-00005
Malfunction
Available
catalog number
2022-03-08
3005172759-2022-00004
Malfunction
Available
catalog number
2021-10-05
3005172759-2021-00014
Malfunction
Available
catalog number
2021-08-27
3005172759-2021-00011
Malfunction
Available
catalog number
Showing the most recent 8 of 23 linked reports.
Regulatory clearances
510(k)K201115Substantially equivalent (SESE) · 2020-08-27clearance 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.