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.
9 linked reportsMalfunction 5Injury 4
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
1.72
2019-02
0
1.51
2019-03
0
1.61
2019-04
0
1.65
2019-05
0
1.83
2019-06
0
1.82
2019-07
0
1.42
2019-08
0
1.98
2019-09
0
1.54
2019-10
0
1.79
2019-11
0
1.53
2019-12
0
1.75
2020-01
0
1.87
2020-02
0
2.07
2020-03
0
1.64
2020-04
0
1.59
2020-05
0
1.56
2020-06
0
1.91
2020-07
0
1.94
2020-08
0
1.8
2020-09
0
2
2020-10
0
2.06
2020-11
0
1.86
2020-12
0
1.78
2021-01
0
1.88
2021-02
0
1.8
2021-03
0
1.93
2021-04
0
1.89
2021-05
0
1.65
2021-06
0
1.54
2021-07
0
1.94
2021-08
0
2.15
2021-09
0
1.7
2021-10
0
1.85
2021-11
0
1.93
2021-12
0
1.93
2022-01
0
2.12
2022-02
0
2.14
2022-03
0
1.81
2022-04
0
2.03
2022-05
0
1.82
2022-06
0
2.09
2022-07
0
2.09
2022-08
0
1.95
2022-09
0
1.85
2022-10
0
1.73
2022-11
0
1.91
2022-12
0
1.76
2023-01
0
1.7
2023-02
0
1.74
2023-03
0
1.81
2023-04
0
1.88
2023-05
0
1.87
2023-06
0
2.04
2023-07
0
1.93
2023-08
0
1.56
2023-09
0
1.41
2023-10
0
1.51
2023-11
0
1.57
2023-12
0
1.36
2024-01
0
1.71
2024-02
0
1.68
2024-03
0
1.55
2024-04
0
1.71
2024-05
0
1.57
2024-06
0
1.82
2024-07
2
1.52
2024-08
0
1.62
2024-09
1
1.58
2024-10
0
1.59
2024-11
0
1.52
2024-12
0
1.55
2025-01
0
1.66
2025-02
0
1.52
2025-03
0
1.73
2025-04
0
1.62
2025-05
3
1.75
2025-06
0
1.76
2025-07
0
1.62
2025-08
0
1.57
2025-09
0
1.41
2025-10
2
1.51
2025-11
0
1.71
2025-12
0
2.12
2026-01
0
1.81
2026-02
0
1.66
2026-03
0
1.64
2026-04
1
1.69
2026-05
0
1.59
2026-06
0
1.61
This device (reports/month)Average device in HSD, KWS, KWT, MBF, PAO (reports/device/month)
Failure-mode summaryAI-generated
9 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
Date
Report #
Type
Narrative
Link basis
2026-04-06
1818910-2026-05981
Injury
Available
exact di
2025-10-27
1818910-2025-18341
Injury
Available
exact di
2025-10-23
1818910-2025-18115
Injury
Available
exact di
2025-05-17
1818910-2025-08059
Malfunction
Available
catalog number
2025-05-08
1818910-2025-07446
Injury
Available
exact di
2024-09-26
1818910-2024-20247
Malfunction
Available
exact di
2024-07-08
1818910-2024-14690
Malfunction
Available
exact di
2024-07-08
1818910-2024-14691
Malfunction
Available
exact di
Showing the most recent 8 of 9 linked reports.
Regulatory clearances
510(k)K212933Substantially equivalent (SESE) · 2022-06-08clearance 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.