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.
103 linked reportsMalfunction 102Injury 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
4
2.71
2019-02
0
3.25
2019-03
0
3.75
2019-04
5
3.25
2019-05
0
3.8
2019-06
0
3.33
2019-07
6
3.2
2019-08
0
2.5
2019-09
0
5.25
2019-10
5
4.1
2019-11
0
3.5
2019-12
0
3.83
2020-01
2
2.38
2020-02
0
2.86
2020-03
0
3.11
2020-04
3
3.4
2020-05
0
3
2020-06
0
4.6
2020-07
3
3.64
2020-08
0
2.33
2020-09
0
4.5
2020-10
6
3
2020-11
0
7.33
2020-12
0
3.13
2021-01
4
2.44
2021-02
0
2.56
2021-03
0
5
2021-04
3
2.88
2021-05
0
4.17
2021-06
2
2.16
2021-07
3
3
2021-08
0
1.29
2021-09
0
1.8
2021-10
3
1.33
2021-11
0
2.33
2021-12
0
2.25
2022-01
3
1.5
2022-02
0
1.75
2022-03
0
1.33
2022-04
3
1.9
2022-05
0
1
2022-06
0
2.17
2022-07
5
2.07
2022-08
0
1.33
2022-09
0
1.25
2022-10
3
1.71
2022-11
0
2.4
2022-12
0
1
2023-01
2
1.5
2023-02
0
1
2023-03
0
1.22
2023-04
2
1.64
2023-05
0
1.2
2023-06
0
1.25
2023-07
3
1.73
2023-08
0
1.43
2023-09
0
2
2023-10
3
1.88
2023-11
0
2
2023-12
0
1.57
2024-01
2
1.31
2024-02
0
1.44
2024-03
0
1.6
2024-04
0
1.56
2024-05
0
1.33
2024-06
0
1
2024-07
2
1.67
2024-08
0
1.57
2024-09
0
2.09
2024-10
4
1.45
2024-11
0
1.46
2024-12
0
1.5
2025-01
4
1.53
2025-02
0
1.71
2025-03
0
1.55
2025-04
4
1.61
2025-05
0
1.82
2025-06
0
1.44
2025-07
4
1.47
2025-08
0
3.25
2025-09
0
1.33
2025-10
4
2
2025-11
0
1.43
2025-12
0
2.33
2026-01
4
2
2026-02
0
1
2026-03
0
1.25
2026-04
2
1.84
2026-05
0
2.71
2026-06
0
3.74
This device (reports/month)Average device in HBB (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
2026-04-22
3015967359-2026-99234
Malfunction
Available
exact di
2026-04-22
3015967359-2026-99230
Malfunction
Available
exact di
2026-01-23
3015967359-2026-99060
Malfunction
Available
exact di
2026-01-23
3015967359-2026-99018
Malfunction
Available
exact di
2026-01-23
3015967359-2026-99051
Malfunction
Available
exact di
2026-01-23
3015967359-2026-99045
Malfunction
Available
exact di
2025-10-28
3015967359-2025-99449
Malfunction
Available
exact di
2025-10-28
3015967359-2025-99510
Malfunction
Available
exact di
2025-10-28
3015967359-2025-99465
Malfunction
Available
exact di
2025-10-28
3015967359-2025-99479
Malfunction
Available
exact di
2025-07-29
3015967359-2025-99191
Malfunction
Available
exact di
2025-07-29
3015967359-2025-99186
Malfunction
Available
exact di
2025-07-29
3015967359-2025-99220
Malfunction
Available
exact di
2025-07-24
3015967359-2025-99110
Malfunction
Available
exact di
2025-04-21
3015967359-2025-00814
Malfunction
Available
exact di
Showing the most recent 102 of 103 linked reports.