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.
123 linked reportsMalfunction 122Injury 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
0
2.16
2019-02
1
1.22
2019-03
0
1.65
2019-04
1
2
2019-05
2
1.94
2019-06
2
1.5
2019-07
1
1.83
2019-08
1
1.5
2019-09
3
2.24
2019-10
3
4.32
2019-11
2
2.15
2019-12
3
2.25
2020-01
3
2
2020-02
0
1.89
2020-03
1
2.33
2020-04
0
2.29
2020-05
0
1.46
2020-06
3
2
2020-07
0
1.81
2020-08
3
2.33
2020-09
1
1.73
2020-10
1
1.91
2020-11
2
1.57
2020-12
0
2.19
2021-01
2
1.53
2021-02
0
1.64
2021-03
3
1.83
2021-04
6
3.46
2021-05
0
1.43
2021-06
0
1.5
2021-07
3
1.56
2021-08
4
3.23
2021-09
1
2.06
2021-10
0
1.85
2021-11
0
1.86
2021-12
0
1.7
2022-01
1
1.87
2022-02
1
2.23
2022-03
3
2.46
2022-04
1
1.56
2022-05
2
2
2022-06
0
1.88
2022-07
4
3.71
2022-08
2
1.87
2022-09
0
1.7
2022-10
0
2
2022-11
0
2.14
2022-12
2
2.86
2023-01
4
2.81
2023-02
2
2.07
2023-03
1
1.62
2023-04
1
2.11
2023-05
2
1.48
2023-06
0
1.82
2023-07
1
2.13
2023-08
3
2.54
2023-09
1
1.92
2023-10
4
3.36
2023-11
0
2.05
2023-12
0
2.09
2024-01
1
2.33
2024-02
3
3.43
2024-03
0
1.69
2024-04
1
1.82
2024-05
1
1.7
2024-06
0
2.67
2024-07
0
1.33
2024-08
1
1.41
2024-09
0
1.5
2024-10
2
1.97
2024-11
0
2.17
2024-12
3
1.62
2025-01
1
1.82
2025-02
1
1.22
2025-03
0
1.42
2025-04
1
1.47
2025-05
4
3.38
2025-06
1
2.21
2025-07
0
2.23
2025-08
2
1.54
2025-09
0
1
2025-10
2
2.07
2025-11
0
1
2025-12
1
1.4
2026-01
3
3.64
2026-02
0
1.22
2026-03
8
9.44
2026-04
0
1.36
2026-05
0
1.8
2026-06
0
1.36
This device (reports/month)Average device in HTQ (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
2026-03-30
1818910-2026-05456
Malfunction
Available
exact di
2026-03-30
1818910-2026-05458
Malfunction
Available
exact di
2026-03-30
1818910-2026-05445
Malfunction
Available
exact di
2026-03-16
1818910-2026-04862
Malfunction
Available
exact di
2026-03-16
1818910-2026-04864
Malfunction
Available
exact di
2026-03-16
1818910-2026-04865
Malfunction
Available
exact di
2026-03-16
1818910-2026-04866
Malfunction
Available
exact di
2026-03-16
1818910-2026-04863
Malfunction
Available
exact di
2026-01-14
1818910-2026-00815
Malfunction
Available
exact di
2026-01-14
1818910-2026-00818
Malfunction
Available
exact di
2026-01-14
1818910-2026-00820
Malfunction
Available
exact di
2025-12-19
1818910-2025-22242
Malfunction
Available
exact di
2025-10-15
1818910-2025-17480
Malfunction
Available
exact di
2025-10-10
1818910-2025-17443
Malfunction
Available
exact di
2025-08-15
1818910-2025-14261
Malfunction
Available
exact di
Showing the most recent 121 of 123 linked reports.