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.
857 linked reportsMalfunction 850Injury 7
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
5.38
2019-02
0
5.13
2019-03
0
3.47
2019-04
2
5.67
2019-05
2
4.9
2019-06
12
4.6
2019-07
2
4.26
2019-08
4
3.77
2019-09
3
3.47
2019-10
3
3.38
2019-11
1
4.86
2019-12
5
4.13
2020-01
2
4.92
2020-02
0
3.07
2020-03
0
4.94
2020-04
0
2.54
2020-05
0
3.07
2020-06
6
4.33
2020-07
10
3.28
2020-08
12
3.36
2020-09
11
4.41
2020-10
18
5
2020-11
10
5.43
2020-12
9
5.61
2021-01
14
3.89
2021-02
9
4.5
2021-03
10
5.42
2021-04
8
4.39
2021-05
2
4.38
2021-06
5
3.74
2021-07
12
4.4
2021-08
8
6
2021-09
4
3.3
2021-10
8
3.22
2021-11
4
5.09
2021-12
7
4.04
2022-01
7
3.37
2022-02
4
3.21
2022-03
33
6.82
2022-04
13
5.6
2022-05
0
3.58
2022-06
9
4.58
2022-07
9
4
2022-08
39
5.72
2022-09
12
4.8
2022-10
8
4.27
2022-11
6
6.11
2022-12
8
4.86
2023-01
13
5.71
2023-02
10
5.88
2023-03
35
8.4
2023-04
6
3
2023-05
12
5.09
2023-06
13
6.63
2023-07
8
5.18
2023-08
5
5.29
2023-09
3
6.46
2023-10
3
5.11
2023-11
12
4.85
2023-12
2
5.86
2024-01
11
5.2
2024-02
5
3.77
2024-03
13
3.28
2024-04
27
6.07
2024-05
2
2.87
2024-06
17
4
2024-07
2
2.89
2024-08
15
3.17
2024-09
1
3.93
2024-10
5
4.43
2024-11
5
2.85
2024-12
38
4.79
2025-01
15
4
2025-02
6
2.14
2025-03
7
3.37
2025-04
3
2.84
2025-05
23
5
2025-06
2
2.88
2025-07
24
4.14
2025-08
24
6.1
2025-09
4
2.48
2025-10
2
3.56
2025-11
54
5.96
2025-12
13
4.94
2026-01
0
3.4
2026-02
4
4.24
2026-03
25
5.2
2026-04
10
4.84
2026-05
14
3.96
2026-06
13
5.13
This device (reports/month)Average device in HWR (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
1526439-2026-00957
Malfunction
—
exact di
2026-06-25
1526439-2026-00954
Malfunction
—
exact di
2026-06-25
1526439-2026-00953
Malfunction
—
exact di
2026-06-25
1526439-2026-00961
Malfunction
—
exact di
2026-06-25
1526439-2026-00958
Malfunction
—
exact di
2026-06-25
1526439-2026-00956
Malfunction
—
exact di
2026-06-25
1526439-2026-00960
Malfunction
—
exact di
2026-06-25
1526439-2026-00962
Malfunction
—
exact di
2026-06-25
1526439-2026-00959
Malfunction
—
exact di
2026-06-25
1526439-2026-00955
Malfunction
—
exact di
2026-06-05
1526439-2026-00663
Malfunction
Available
exact di
2026-06-05
1526439-2026-00662
Malfunction
Available
exact di
2026-06-04
1526439-2026-00651
Malfunction
Available
exact di
2026-05-27
1526439-2026-00622
Malfunction
Available
exact di
2026-05-27
1526439-2026-00621
Malfunction
Available
exact di
Showing the most recent 200 of 857 linked reports.