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.
15 linked reportsMalfunction 9Injury 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
2.43
2019-02
0
3.17
2019-03
0
2.38
2019-04
0
2.71
2019-05
0
2.2
2019-06
0
1.83
2019-07
0
2.06
2019-08
0
5.89
2019-09
0
2.27
2019-10
0
3.87
2019-11
0
3.75
2019-12
0
3.25
2020-01
0
3
2020-02
0
2.17
2020-03
0
3.43
2020-04
0
2.43
2020-05
0
4.29
2020-06
0
3
2020-07
0
2.67
2020-08
0
2.13
2020-09
0
2.25
2020-10
0
2.67
2020-11
0
2.69
2020-12
0
2.54
2021-01
0
2
2021-02
0
2.67
2021-03
0
2.13
2021-04
0
2.09
2021-05
3
2
2021-06
0
3.23
2021-07
0
4.67
2021-08
0
1.83
2021-09
0
3
2021-10
0
2.67
2021-11
0
2.13
2021-12
0
3.11
2022-01
0
2
2022-02
0
2.8
2022-03
0
4.14
2022-04
0
2.7
2022-05
0
2.5
2022-06
0
4.5
2022-07
0
1.88
2022-08
0
2.86
2022-09
0
2.4
2022-10
6
3
2022-11
0
4
2022-12
0
4
2023-01
0
2.5
2023-02
0
3.29
2023-03
0
4.5
2023-04
0
3.83
2023-05
0
3.5
2023-06
0
3.4
2023-07
0
4.36
2023-08
0
2.79
2023-09
0
3
2023-10
0
2.25
2023-11
0
2
2023-12
0
2.4
2024-01
0
5
2024-02
0
4.43
2024-03
0
2.38
2024-04
0
2
2024-05
0
2.17
2024-06
0
4
2024-07
0
2
2024-08
0
1.83
2024-09
0
1.5
2024-10
0
2
2024-11
0
1.5
2024-12
0
2.14
2025-01
3
2.36
2025-02
0
1
2025-03
0
2
2025-04
0
2.5
2025-05
3
3.71
2025-06
0
1.78
2025-07
0
4.57
2025-08
0
2
2025-09
0
1
2025-10
0
3
2025-11
0
2.75
2025-12
0
2.5
2026-01
0
1.5
2026-02
0
1.8
2026-03
0
3.35
2026-04
0
7.33
2026-05
0
3.44
2026-06
0
4.2
This device (reports/month)Average device in DSY (reports/device/month)
Failure-mode summaryAI-generated
15 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
Date
Report #
Type
Narrative
Link basis
2025-05-19
1640201-2025-0000011
Malfunction
Available
catalog number
2025-01-31
1640201-2025-0000003
Malfunction
Available
catalog number
2022-10-13
2242352-2022-00861
Injury
Available
catalog number
2022-10-10
1640201-2022-00031
Injury
Available
catalog number
2021-05-03
1640201-2021-00010
Malfunction
Available
catalog number
Showing the most recent 5 of 15 linked reports.
Regulatory clearances
510(k)K103347Substantially equivalent (SESE) · 2011-02-02clearance family