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.
355 linked reportsMalfunction 334Injury 20Death 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
2
3.24
2019-02
2
2.11
2019-03
2
1.39
2019-04
1
3.6
2019-05
3
3.28
2019-06
1
1.14
2019-07
2
3.44
2019-08
0
1.13
2019-09
2
1.25
2019-10
1
3.74
2019-11
2
1.33
2019-12
2
1.58
2020-01
0
3.57
2020-02
1
1.93
2020-03
1
2
2020-04
1
2.79
2020-05
1
1
2020-06
1
1.42
2020-07
4
4.9
2020-08
0
1.04
2020-09
1
3.67
2020-10
1
3.5
2020-11
1
1.07
2020-12
4
2.32
2021-01
1
8.24
2021-02
2
1.6
2021-03
5
2.03
2021-04
2
3.06
2021-05
3
6
2021-06
0
1.76
2021-07
2
2.34
2021-08
3
2.8
2021-09
2
1.81
2021-10
4
3.88
2021-11
2
2.08
2021-12
2
3.45
2022-01
1
3.65
2022-02
6
1.68
2022-03
3
1.83
2022-04
5
2.47
2022-05
8
1.41
2022-06
3
2.89
2022-07
8
3.76
2022-08
0
1.26
2022-09
2
2.33
2022-10
3
3.03
2022-11
5
2.31
2022-12
5
3.79
2023-01
6
2.25
2023-02
5
1.47
2023-03
8
3.27
2023-04
5
5.09
2023-05
7
6.26
2023-06
8
3.73
2023-07
2
5.07
2023-08
4
7.5
2023-09
8
5.9
2023-10
5
3.76
2023-11
7
8.22
2023-12
2
8.71
2024-01
10
4.85
2024-02
3
2.5
2024-03
6
7.12
2024-04
10
5.81
2024-05
5
7.91
2024-06
5
9.73
2024-07
7
5.69
2024-08
3
7.77
2024-09
7
6.57
2024-10
3
4.57
2024-11
6
13.53
2024-12
4
7.73
2025-01
10
7.04
2025-02
8
5.57
2025-03
4
4.91
2025-04
5
6.62
2025-05
6
5.12
2025-06
13
9.32
2025-07
8
6.46
2025-08
6
4.02
2025-09
4
9.07
2025-10
4
3.32
2025-11
6
8.51
2025-12
3
8.49
2026-01
2
4.16
2026-02
5
5.84
2026-03
4
6.43
2026-04
6
7.36
2026-05
9
21.67
2026-06
3
32.34
This device (reports/month)Average device in FNL (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
2026-06-25
3007420694-2026-00103
Malfunction
—
exact di
2026-06-24
3007420694-2026-00107
Malfunction
—
exact di
2026-06-02
3007420694-2026-00093
Malfunction
Available
exact di
2026-05-28
3007420694-2026-00092
Malfunction
Available
exact di
2026-05-26
3007420694-2026-00084
Malfunction
Available
exact di
2026-05-18
1419652-2026-00099
Injury
Available
exact di
2026-05-15
3007420694-2026-00080
Malfunction
Available
exact di
2026-05-14
3007420694-2026-00081
Malfunction
Available
exact di
2026-05-13
3007420694-2026-00077
Malfunction
Available
exact di
2026-05-07
25111327
Malfunction
Available
exact di
2026-05-04
3007420694-2026-00076
Malfunction
Available
exact di
2026-04-30
3007420694-2026-00071
Malfunction
Available
exact di
2026-04-17
3007420694-2026-00061
Malfunction
Available
exact di
2026-04-08
3007420694-2026-00064
Malfunction
Available
exact di
2026-04-08
3007420694-2026-00053
Malfunction
Available
exact di
Showing the most recent 200 of 355 linked reports.