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.
328 linked reportsMalfunction 282Injury 46
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
2.23
2019-02
1
2.95
2019-03
0
1.95
2019-04
0
2.54
2019-05
2
2.58
2019-06
0
2.13
2019-07
0
2.88
2019-08
4
2.31
2019-09
1
2.59
2019-10
1
3.55
2019-11
0
2.61
2019-12
0
3.08
2020-01
6
2.65
2020-02
3
2.14
2020-03
0
2.57
2020-04
3
2.06
2020-05
0
2.2
2020-06
0
2.79
2020-07
0
3.4
2020-08
0
3.22
2020-09
3
3.04
2020-10
6
3.82
2020-11
3
4.24
2020-12
24
3.5
2021-01
3
4.53
2021-02
18
3.6
2021-03
3
3.73
2021-04
15
3.42
2021-05
9
3.39
2021-06
0
3.09
2021-07
9
3.34
2021-08
4
2.55
2021-09
3
3.23
2021-10
7
2.68
2021-11
6
3.38
2021-12
0
3.64
2022-01
9
3.69
2022-02
0
3.36
2022-03
6
3.02
2022-04
3
3.35
2022-05
3
2.79
2022-06
9
2.88
2022-07
6
3.37
2022-08
3
3.33
2022-09
9
4.38
2022-10
0
2.97
2022-11
3
3.63
2022-12
0
3.15
2023-01
6
3.5
2023-02
0
3.32
2023-03
6
3.94
2023-04
6
3.01
2023-05
15
4.21
2023-06
0
3.57
2023-07
0
3.65
2023-08
2
2.96
2023-09
2
2.53
2023-10
0
2.7
2023-11
2
2.46
2023-12
4
2.32
2024-01
8
2.51
2024-02
8
2.89
2024-03
2
2.61
2024-04
2
2.38
2024-05
2
3.31
2024-06
6
3
2024-07
6
3.19
2024-08
0
2.25
2024-09
0
3.85
2024-10
3
2.67
2024-11
3
2.56
2024-12
5
1.94
2025-01
0
5.71
2025-02
0
4.27
2025-03
5
2.71
2025-04
3
2.89
2025-05
2
3.18
2025-06
3
2.74
2025-07
3
2.97
2025-08
6
3.06
2025-09
2
2.47
2025-10
0
2.19
2025-11
0
2.86
2025-12
15
3.46
2026-01
15
3.06
2026-02
0
2.46
2026-03
1
2.72
2026-04
0
2.96
2026-05
0
2.98
2026-06
0
3.27
This device (reports/month)Average device in HXX (reports/device/month)
Failure-mode summaryAI-generated
40 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
Date
Report #
Type
Narrative
Link basis
2026-03-20
3005739886-2026-00017
Injury
Available
exact di
2026-01-06
3005739886-2026-00004
Malfunction
Available
catalog number
2026-01-06
3005739886-2026-00003
Malfunction
Available
catalog number
2026-01-06
3005739886-2026-00002
Malfunction
Available
catalog number
2026-01-06
3005739886-2026-00001
Malfunction
Available
catalog number
2026-01-06
3005739886-2026-00005
Malfunction
Available
catalog number
2025-12-31
3005739886-2025-00024
Malfunction
Available
catalog number
2025-12-31
3005739886-2025-00025
Malfunction
Available
catalog number
2025-12-12
3005739886-2025-00021
Malfunction
Available
catalog number
2025-12-12
3005739886-2025-00020
Malfunction
Available
catalog number
2025-12-09
3005739886-2025-00019
Malfunction
Available
catalog number
2025-09-30
3005739886-2025-00017
Malfunction
Available
catalog number
2025-08-20
3005739886-2025-00016
Malfunction
Available
catalog number
2025-08-11
3005739886-2025-00013
Malfunction
Available
catalog number
2025-07-11
3005739886-2025-00011
Malfunction
Available
catalog number
Showing the most recent 128 of 328 linked reports.