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.
166 linked reportsMalfunction 162Injury 4
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
0
1.94
2019-06
0
1.5
2019-07
1
1.83
2019-08
2
1.5
2019-09
3
2.24
2019-10
4
4.32
2019-11
4
2.15
2019-12
0
2.25
2020-01
0
2
2020-02
1
1.89
2020-03
3
2.33
2020-04
2
2.29
2020-05
0
1.46
2020-06
4
2
2020-07
2
1.81
2020-08
4
2.33
2020-09
3
1.73
2020-10
3
1.91
2020-11
1
1.57
2020-12
2
2.19
2021-01
5
1.53
2021-02
3
1.64
2021-03
1
1.83
2021-04
7
3.46
2021-05
2
1.43
2021-06
0
1.5
2021-07
1
1.56
2021-08
5
3.23
2021-09
1
2.06
2021-10
1
1.85
2021-11
1
1.86
2021-12
1
1.7
2022-01
4
1.87
2022-02
4
2.23
2022-03
1
2.46
2022-04
0
1.56
2022-05
1
2
2022-06
2
1.88
2022-07
4
3.71
2022-08
2
1.87
2022-09
2
1.7
2022-10
0
2
2022-11
2
2.14
2022-12
1
2.86
2023-01
6
2.81
2023-02
2
2.07
2023-03
1
1.62
2023-04
2
2.11
2023-05
1
1.48
2023-06
0
1.82
2023-07
2
2.13
2023-08
5
2.54
2023-09
3
1.92
2023-10
4
3.36
2023-11
0
2.05
2023-12
0
2.09
2024-01
2
2.33
2024-02
0
3.43
2024-03
0
1.69
2024-04
0
1.82
2024-05
1
1.7
2024-06
1
2.67
2024-07
0
1.33
2024-08
1
1.41
2024-09
0
1.5
2024-10
1
1.97
2024-11
2
2.17
2024-12
4
1.62
2025-01
1
1.82
2025-02
0
1.22
2025-03
1
1.42
2025-04
2
1.47
2025-05
5
3.38
2025-06
4
2.21
2025-07
2
2.23
2025-08
3
1.54
2025-09
1
1
2025-10
2
2.07
2025-11
0
1
2025-12
2
1.4
2026-01
4
3.64
2026-02
1
1.22
2026-03
6
9.44
2026-04
1
1.36
2026-05
1
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
2026-05-04
1818910-2026-08157
Malfunction
Available
exact di
2026-04-28
1818910-2026-07719
Malfunction
Available
exact di
2026-03-30
1818910-2026-05459
Malfunction
Available
exact di
2026-03-30
1818910-2026-05462
Malfunction
Available
exact di
2026-03-30
1818910-2026-05461
Malfunction
Available
exact di
2026-03-12
1818910-2026-04716
Malfunction
Available
exact di
2026-03-11
1818910-2026-04594
Malfunction
Available
catalog number
2026-03-11
1818910-2026-04595
Malfunction
Available
catalog number
2026-02-10
1818910-2026-02736
Malfunction
Available
exact di
2026-01-14
1818910-2026-00814
Malfunction
Available
exact di
2026-01-14
1818910-2026-00822
Malfunction
Available
exact di
2026-01-14
1818910-2026-00823
Malfunction
Available
exact di
2026-01-09
1818910-2026-00452
Malfunction
Available
exact di
2025-12-18
1818910-2025-22147
Malfunction
Available
exact di
2025-12-01
1818910-2025-20850
Malfunction
Available
exact di
Showing the most recent 163 of 166 linked reports.