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.
30 linked reportsMalfunction 30
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
3.35
2019-02
0
3.8
2019-03
0
4.32
2019-04
0
5.21
2019-05
0
4.82
2019-06
0
4.56
2019-07
0
4.67
2019-08
0
4.81
2019-09
0
4.44
2019-10
0
4.92
2019-11
0
7.39
2019-12
0
4.74
2020-01
0
4.47
2020-02
0
3.96
2020-03
0
4.27
2020-04
0
3.54
2020-05
0
3.18
2020-06
0
3.93
2020-07
0
5.87
2020-08
0
4.09
2020-09
0
5.07
2020-10
0
3.93
2020-11
0
4.83
2020-12
0
4.52
2021-01
0
3.28
2021-02
0
3.57
2021-03
0
3.8
2021-04
0
3.63
2021-05
0
3.76
2021-06
0
4.41
2021-07
0
4.6
2021-08
0
3.78
2021-09
0
3.91
2021-10
0
4.26
2021-11
0
4.05
2021-12
0
4.14
2022-01
0
4.32
2022-02
0
3.58
2022-03
0
4.09
2022-04
0
4.56
2022-05
0
3.55
2022-06
0
4.3
2022-07
0
2.88
2022-08
0
3
2022-09
0
2.72
2022-10
0
3.36
2022-11
0
3.21
2022-12
0
3.59
2023-01
0
3.12
2023-02
0
3.1
2023-03
0
3.88
2023-04
0
3.96
2023-05
0
3.58
2023-06
0
3.76
2023-07
0
3.29
2023-08
0
3.86
2023-09
0
4.26
2023-10
0
4.16
2023-11
0
3.68
2023-12
0
4.25
2024-01
0
3.96
2024-02
0
4.84
2024-03
0
4.27
2024-04
0
4.28
2024-05
0
4.51
2024-06
0
3.82
2024-07
0
3.72
2024-08
0
4.71
2024-09
0
4.83
2024-10
3
4.06
2024-11
0
6.08
2024-12
2
7.13
2025-01
0
5.31
2025-02
0
4.53
2025-03
0
4.15
2025-04
0
3.78
2025-05
0
8.01
2025-06
3
5.16
2025-07
4
4.33
2025-08
0
3.94
2025-09
6
4.63
2025-10
0
6.3
2025-11
0
5.3
2025-12
3
4.67
2026-01
0
4.39
2026-02
3
4.59
2026-03
0
5.38
2026-04
0
5.69
2026-05
3
7.17
2026-06
3
4.62
This device (reports/month)Average device in FDI, KNS, PKL (reports/device/month)
Failure-mode summaryAI-generated
30 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
Date
Report #
Type
Narrative
Link basis
2026-06-04
1528319-2026-00063
Malfunction
Available
catalog number
2026-05-21
1528319-2026-00054
Malfunction
Available
catalog number
2026-02-05
1528319-2026-00008
Malfunction
Available
catalog number
2025-12-05
1528319-2025-00111
Malfunction
Available
catalog number
2025-09-19
1528319-2025-00095
Malfunction
Available
catalog number
2025-09-18
1528319-2025-00094
Malfunction
Available
catalog number
2025-07-25
1528319-2025-00079
Malfunction
Available
catalog number
2025-06-27
1528319-2025-00072
Malfunction
Available
catalog number
2024-12-20
1528319-2024-00111
Malfunction
Available
catalog number
2024-10-31
1528319-2024-00095
Malfunction
Available
catalog number
Showing the most recent 10 of 30 linked reports.
Regulatory clearances
510(k)K250842Substantially equivalent (SESE) · 2025-04-18clearance family
510(k)K240274Substantially equivalent (SESE) · 2024-09-17clearance 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.