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 reportsInjury 1Malfunction 1
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
1.97
2019-02
0
2.17
2019-03
0
1.83
2019-04
0
2.24
2019-05
0
2.5
2019-06
0
1.83
2019-07
0
2.12
2019-08
0
2.45
2019-09
0
1.94
2019-10
0
1.96
2019-11
0
1.64
2019-12
0
1.77
2020-01
0
1.88
2020-02
0
1.86
2020-03
0
2.51
2020-04
0
1.67
2020-05
0
1.84
2020-06
0
2
2020-07
0
2.72
2020-08
0
1.85
2020-09
0
1.99
2020-10
0
2.24
2020-11
0
1.9
2020-12
0
1.84
2021-01
0
2.32
2021-02
0
2.04
2021-03
0
2.16
2021-04
0
2.28
2021-05
0
2.04
2021-06
0
2.19
2021-07
0
2.15
2021-08
0
2.39
2021-09
0
2.06
2021-10
0
2.68
2021-11
0
2.21
2021-12
0
3.01
2022-01
0
3.04
2022-02
0
2.59
2022-03
0
2.87
2022-04
0
2.75
2022-05
0
2.19
2022-06
0
2.32
2022-07
0
2.19
2022-08
0
2.33
2022-09
0
2.1
2022-10
0
2.06
2022-11
0
2.21
2022-12
0
2.14
2023-01
0
1.86
2023-02
0
1.94
2023-03
0
1.94
2023-04
0
2.41
2023-05
0
2.02
2023-06
0
2.15
2023-07
0
1.96
2023-08
0
1.67
2023-09
0
1.56
2023-10
0
1.61
2023-11
0
1.76
2023-12
0
1.43
2024-01
0
1.61
2024-02
0
1.98
2024-03
0
1.63
2024-04
0
1.83
2024-05
0
1.63
2024-06
0
1.75
2024-07
0
1.63
2024-08
0
1.65
2024-09
1
1.59
2024-10
0
1.7
2024-11
1
1.54
2024-12
0
1.53
2025-01
0
1.68
2025-02
0
1.61
2025-03
0
1.87
2025-04
0
1.66
2025-05
0
1.84
2025-06
0
1.96
2025-07
0
1.76
2025-08
0
1.63
2025-09
0
1.41
2025-10
0
1.59
2025-11
0
1.7
2025-12
0
2.29
2026-01
0
1.96
2026-02
0
1.71
2026-03
0
1.73
2026-04
0
1.73
2026-05
0
1.68
2026-06
0
1.75
This device (reports/month)Average device in MBF, PAO, PHX (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
2024-11-12
1818910-2024-23476
Injury
Available
exact di
2024-09-06
1818910-2024-18857
Malfunction
Available
exact di
Regulatory clearances
510(k)K221467Substantially equivalent (SESE) · 2022-08-31clearance 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.