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.
6 linked reportsMalfunction 6
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
3.54
2019-02
0
1.87
2019-03
0
2.04
2019-04
0
2.45
2019-05
0
2.22
2019-06
0
2.15
2019-07
0
2.45
2019-08
0
2.4
2019-09
0
2.54
2019-10
0
2.34
2019-11
0
3.11
2019-12
1
3.28
2020-01
0
3.2
2020-02
0
2.57
2020-03
0
2.65
2020-04
0
3.16
2020-05
0
2.36
2020-06
0
2.68
2020-07
0
2.88
2020-08
0
3.06
2020-09
0
2.84
2020-10
0
3.01
2020-11
0
4
2020-12
0
3.65
2021-01
0
2.77
2021-02
0
2.94
2021-03
0
3.06
2021-04
0
3.16
2021-05
0
3.13
2021-06
0
2.88
2021-07
0
2.82
2021-08
0
2.84
2021-09
0
3.14
2021-10
0
3.16
2021-11
0
3.13
2021-12
0
3.24
2022-01
0
3.6
2022-02
0
2.76
2022-03
0
2.94
2022-04
0
2.69
2022-05
0
2.91
2022-06
0
2.81
2022-07
0
2.76
2022-08
0
3.25
2022-09
0
3.21
2022-10
0
3.57
2022-11
0
2.8
2022-12
0
4.31
2023-01
0
3.23
2023-02
0
2.94
2023-03
0
3.37
2023-04
0
3.35
2023-05
0
3.73
2023-06
0
3.66
2023-07
0
2.95
2023-08
0
3.16
2023-09
1
3.27
2023-10
0
3.21
2023-11
0
3.24
2023-12
1
3.89
2024-01
0
4.03
2024-02
0
3.06
2024-03
1
3.52
2024-04
0
3.49
2024-05
0
4.03
2024-06
0
4.49
2024-07
0
3.24
2024-08
0
3.03
2024-09
0
3.49
2024-10
0
3.47
2024-11
1
3.32
2024-12
0
3.68
2025-01
0
3.9
2025-02
0
3.43
2025-03
0
3.36
2025-04
0
3.68
2025-05
1
3.91
2025-06
0
3.73
2025-07
0
3.7
2025-08
0
3.75
2025-09
0
3.46
2025-10
0
3.78
2025-11
0
3.85
2025-12
0
4.64
2026-01
0
4.1
2026-02
0
4.3
2026-03
0
4.3
2026-04
0
4.13
2026-05
0
4.85
2026-06
0
4.54
This device (reports/month)Average device in HTY, HWC, JDR, MAI, MBI (reports/device/month)
Failure-mode summaryAI-generated
6 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
Date
Report #
Type
Narrative
Link basis
2025-05-16
1221934-2025-01759
Malfunction
Available
exact di
2024-11-26
1221934-2024-04219
Malfunction
Available
exact di
2024-03-06
1221934-2024-00763
Malfunction
Available
exact di
2023-12-05
1221934-2023-04375
Malfunction
Available
exact di
2023-09-15
1221934-2023-03447
Malfunction
Available
exact di
2019-12-17
1221934-2019-60011
Malfunction
Available
exact di
Regulatory clearances
510(k)K103712Substantially equivalent (SESE) · 2011-03-11clearance 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.