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.
2 linked reportsMalfunction 2
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
1.52
2019-02
0
1.3
2019-03
0
1.72
2019-04
0
1.4
2019-05
0
1.56
2019-06
0
1.62
2019-07
0
1.61
2019-08
0
1.35
2019-09
0
1.66
2019-10
0
1.97
2019-11
0
1.55
2019-12
0
1.44
2020-01
0
1.69
2020-02
0
1.85
2020-03
0
1.52
2020-04
0
1.4
2020-05
0
1.59
2020-06
0
2.1
2020-07
0
2.24
2020-08
0
1.58
2020-09
0
2.78
2020-10
0
2.16
2020-11
0
2.38
2020-12
0
1.64
2021-01
0
1.81
2021-02
0
1.76
2021-03
0
1.94
2021-04
0
1.63
2021-05
0
2
2021-06
0
2.36
2021-07
0
1.83
2021-08
0
2.35
2021-09
0
1.72
2021-10
0
2.27
2021-11
0
1.91
2021-12
0
2.72
2022-01
0
3.24
2022-02
0
2.85
2022-03
0
1.82
2022-04
0
1.76
2022-05
0
2.28
2022-06
0
1.74
2022-07
0
2.14
2022-08
0
2.07
2022-09
0
1.88
2022-10
0
1.84
2022-11
0
1.86
2022-12
0
1.67
2023-01
0
2.27
2023-02
0
1.96
2023-03
0
1.72
2023-04
0
1.87
2023-05
0
1.91
2023-06
0
1.64
2023-07
0
2
2023-08
0
1.7
2023-09
0
1.9
2023-10
0
1.73
2023-11
0
8.42
2023-12
0
3.45
2024-01
0
1.87
2024-02
0
2.08
2024-03
0
1.84
2024-04
0
1.46
2024-05
0
1.76
2024-06
0
1.81
2024-07
0
1.97
2024-08
0
2.19
2024-09
0
1.87
2024-10
0
2.1
2024-11
0
1.76
2024-12
0
1.82
2025-01
0
1.82
2025-02
0
1.63
2025-03
0
1.64
2025-04
2
1.59
2025-05
0
1.64
2025-06
0
1.96
2025-07
0
1.95
2025-08
0
1.61
2025-09
0
1.68
2025-10
0
1.72
2025-11
0
1.91
2025-12
0
1.83
2026-01
0
1.83
2026-02
0
1.5
2026-03
0
2.67
2026-04
0
1.6
2026-05
0
1.57
2026-06
0
1.62
This device (reports/month)Average device in MAX, OVD (reports/device/month)
Failure-mode summaryAI-generated
2 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
Date
Report #
Type
Narrative
Link basis
2025-04-24
2031966-2025-00075
Malfunction
Available
exact di
Showing the most recent 1 of 2 linked reports.
Regulatory clearances
510(k)K230894Substantially equivalent (SESE) · 2023-06-16clearance 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.