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.
590 linked reportsMalfunction 581Injury 9
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
49
8.68
2019-02
2
4.09
2019-03
3
4.28
2019-04
2
5.72
2019-05
5
4.66
2019-06
2
4.69
2019-07
7
5.29
2019-08
5
5.49
2019-09
3
4.89
2019-10
6
5.7
2019-11
8
5.36
2019-12
2
5.38
2020-01
6
4.89
2020-02
8
5.62
2020-03
15
5.67
2020-04
2
3.9
2020-05
4
3.67
2020-06
5
5.28
2020-07
3
6.47
2020-08
4
4.87
2020-09
11
6.3
2020-10
11
6.31
2020-11
9
5.33
2020-12
21
6.21
2021-01
10
5.44
2021-02
5
5.12
2021-03
15
6.3
2021-04
5
5.52
2021-05
12
5.28
2021-06
9
5.8
2021-07
8
4.91
2021-08
6
4.51
2021-09
5
4.47
2021-10
8
5.88
2021-11
9
5.03
2021-12
9
5.53
2022-01
5
5.02
2022-02
8
4.86
2022-03
6
5.39
2022-04
4
4.77
2022-05
4
5.41
2022-06
9
5.79
2022-07
3
4.36
2022-08
6
4.53
2022-09
3
4.78
2022-10
5
4.6
2022-11
8
4.64
2022-12
4
4.19
2023-01
7
5.43
2023-02
4
4.54
2023-03
2
4.96
2023-04
3
4.79
2023-05
5
5.07
2023-06
5
4.7
2023-07
5
4.69
2023-08
5
4.59
2023-09
2
5.12
2023-10
8
4.92
2023-11
4
5.26
2023-12
6
5.91
2024-01
2
5.71
2024-02
5
5.73
2024-03
2
5.93
2024-04
8
6.02
2024-05
9
6.9
2024-06
6
6.3
2024-07
6
5.02
2024-08
6
4.98
2024-09
7
5.08
2024-10
8
5.81
2024-11
5
5.28
2024-12
2
4.95
2025-01
15
6.1
2025-02
7
4.85
2025-03
4
5.97
2025-04
4
4.62
2025-05
6
5.36
2025-06
5
5.08
2025-07
3
5.22
2025-08
6
5.17
2025-09
5
4.78
2025-10
1
5.13
2025-11
11
5.58
2025-12
7
5.84
2026-01
5
5.6
2026-02
5
5.87
2026-03
1
6.06
2026-04
8
5.83
2026-05
7
5.8
2026-06
9
5.42
This device (reports/month)Average device in GEI, HRX (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
2026-06-30
1221934-2026-02859
Malfunction
—
exact di
2026-06-24
1221934-2026-02765
Malfunction
—
exact di
2026-06-22
1221934-2026-02719
Malfunction
Available
exact di
2026-06-19
1221934-2026-02707
Malfunction
Available
exact di
2026-06-18
1221934-2026-02657
Malfunction
Available
exact di
2026-06-15
1221934-2026-02566
Malfunction
Available
exact di
2026-06-15
1221934-2026-02594
Malfunction
Available
exact di
2026-06-05
1221934-2026-02423
Malfunction
Available
exact di
2026-06-01
1221934-2026-02351
Malfunction
Available
exact di
2026-05-28
1221934-2026-02302
Malfunction
Available
exact di
2026-05-26
1221934-2026-02166
Malfunction
Available
exact di
2026-05-21
1221934-2026-02127
Malfunction
Available
exact di
2026-05-20
1221934-2026-02117
Malfunction
Available
exact di
2026-05-19
1221934-2026-02094
Malfunction
Available
exact di
2026-05-18
1221934-2026-02072
Malfunction
Available
exact di
Showing the most recent 200 of 590 linked reports.