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.
259 linked reportsMalfunction 252Injury 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
1.69
2019-02
0
3.17
2019-03
0
8.24
2019-04
0
4.93
2019-05
0
3.58
2019-06
0
4.13
2019-07
0
3.46
2019-08
0
4.29
2019-09
0
3.62
2019-10
0
3.65
2019-11
0
4
2019-12
0
4.41
2020-01
1
4.42
2020-02
0
3.64
2020-03
0
4.46
2020-04
0
3.95
2020-05
0
2.68
2020-06
0
5.32
2020-07
0
5
2020-08
1
3.79
2020-09
0
4.43
2020-10
3
4.07
2020-11
0
3.86
2020-12
0
5.38
2021-01
0
3.38
2021-02
0
4.09
2021-03
0
5.17
2021-04
4
3.69
2021-05
6
4.2
2021-06
13
5.35
2021-07
7
4.37
2021-08
5
4.07
2021-09
0
3.4
2021-10
5
2.62
2021-11
4
4.2
2021-12
3
3.1
2022-01
3
3.23
2022-02
3
3.12
2022-03
3
3.19
2022-04
9
3.41
2022-05
3
2.68
2022-06
5
4.21
2022-07
3
3
2022-08
8
4.21
2022-09
3
3.56
2022-10
2
3.26
2022-11
7
4.74
2022-12
3
4.26
2023-01
6
3.58
2023-02
3
3.65
2023-03
4
3.45
2023-04
3
4.71
2023-05
3
4.52
2023-06
2
3.91
2023-07
4
5.19
2023-08
0
3.08
2023-09
0
4.05
2023-10
2
3.11
2023-11
0
3.2
2023-12
2
3.5
2024-01
0
3.95
2024-02
3
4.11
2024-03
0
3.56
2024-04
1
4
2024-05
0
2.63
2024-06
0
3.5
2024-07
2
3.28
2024-08
4
3.17
2024-09
7
5.39
2024-10
3
3.38
2024-11
1
3.32
2024-12
1
4.15
2025-01
2
4
2025-02
49
7.82
2025-03
42
9.65
2025-04
2
2.83
2025-05
1
3.21
2025-06
2
3
2025-07
1
4.3
2025-08
4
3.48
2025-09
0
3.33
2025-10
0
4.67
2025-11
1
2.91
2025-12
0
2.64
2026-01
0
2.6
2026-02
0
2.94
2026-03
0
3.8
2026-04
0
3.86
2026-05
0
3
2026-06
0
1.85
This device (reports/month)Average device in HBC (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
2025-11-07
1625507-2025-02275
Malfunction
Available
exact di
2025-08-12
1625507-2025-01930
Malfunction
Available
exact di
2025-08-12
1625507-2025-01931
Malfunction
Available
exact di
2025-08-11
1625507-2025-01925
Malfunction
Available
exact di
2025-08-11
1625507-2025-01924
Malfunction
Available
exact di
2025-07-23
1625507-2025-01846
Malfunction
Available
exact di
2025-06-11
1625507-2025-01676
Malfunction
Available
exact di
2025-06-04
1625507-2025-01640
Malfunction
Available
exact di
2025-05-19
1625507-2025-01597
Malfunction
Available
exact di
2025-04-17
1625507-2025-01443
Malfunction
Available
exact di
2025-04-03
1625507-2025-01226
Malfunction
Available
exact di
2025-03-26
1625507-2025-01088
Malfunction
Available
exact di
2025-03-26
1625507-2025-01085
Malfunction
Available
exact di
2025-03-26
1625507-2025-01066
Malfunction
Available
exact di
2025-03-26
1625507-2025-01077
Malfunction
Available
exact di
Showing the most recent 200 of 259 linked reports.
Showing 1–15 of 200
Regulatory clearances
510(k)K170312Substantially equivalent (SESE) · 2017-05-15clearance family
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.