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
1.7
2019-04
0
1.4
2019-05
0
1.56
2019-06
0
1.61
2019-07
0
1.6
2019-08
0
1.35
2019-09
0
1.66
2019-10
0
1.97
2019-11
0
1.55
2019-12
0
1.43
2020-01
0
1.69
2020-02
0
1.86
2020-03
0
1.5
2020-04
0
1.4
2020-05
0
1.59
2020-06
0
2.07
2020-07
0
2.23
2020-08
0
1.59
2020-09
0
2.78
2020-10
0
2.13
2020-11
0
2.37
2020-12
0
1.64
2021-01
0
1.81
2021-02
0
1.77
2021-03
0
1.95
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
2.67
2022-01
0
3.2
2022-02
0
2.82
2022-03
0
1.8
2022-04
0
1.77
2022-05
0
2.28
2022-06
0
1.75
2022-07
0
2.18
2022-08
0
2.07
2022-09
0
1.89
2022-10
0
1.84
2022-11
0
1.87
2022-12
0
1.67
2023-01
0
2.25
2023-02
0
2
2023-03
0
1.73
2023-04
0
1.91
2023-05
0
1.91
2023-06
0
1.65
2023-07
0
2
2023-08
0
1.75
2023-09
0
1.91
2023-10
0
1.76
2023-11
0
8.27
2023-12
0
3.32
2024-01
0
1.94
2024-02
0
2.1
2024-03
0
1.85
2024-04
0
1.48
2024-05
0
1.93
2024-06
0
1.85
2024-07
0
1.98
2024-08
0
2.18
2024-09
0
1.88
2024-10
0
2.15
2024-11
0
1.74
2024-12
0
1.88
2025-01
0
1.82
2025-02
0
1.67
2025-03
0
1.67
2025-04
0
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
1.73
2025-10
0
1.72
2025-11
0
1.91
2025-12
0
1.84
2026-01
0
1.79
2026-02
2
1.52
2026-03
0
2.66
2026-04
0
1.68
2026-05
0
1.57
2026-06
0
1.68
This device (reports/month)Average device in MAX, OVD, PHM (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
2026-02-12
2031966-2026-00023
Malfunction
Available
exact di
Showing the most recent 1 of 2 linked reports.
Regulatory clearances
510(k)K201692Substantially equivalent (SESE) · 2020-10-29clearance 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.