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.
10 linked reportsInjury 7Malfunction 3
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
2.33
2019-02
0
5.57
2019-03
0
3.05
2019-04
0
3
2019-05
0
2.93
2019-06
0
4.08
2019-07
0
4.11
2019-08
0
5
2019-09
0
2.93
2019-10
0
3.08
2019-11
0
2.73
2019-12
0
2.67
2020-01
0
3
2020-02
0
1.92
2020-03
0
1.95
2020-04
0
1.86
2020-05
0
1.59
2020-06
0
1.4
2020-07
0
1.73
2020-08
0
1.7
2020-09
0
1.69
2020-10
0
2.94
2020-11
0
2
2020-12
0
2.15
2021-01
0
2.43
2021-02
1
2.2
2021-03
0
2.91
2021-04
0
2.33
2021-05
0
2.07
2021-06
0
2.86
2021-07
0
2.2
2021-08
0
1.76
2021-09
0
2.68
2021-10
0
1.64
2021-11
0
2.59
2021-12
0
2.06
2022-01
0
3
2022-02
0
1.95
2022-03
0
2.36
2022-04
0
2.32
2022-05
0
2.82
2022-06
4
2.64
2022-07
0
4.07
2022-08
0
3.8
2022-09
0
3.67
2022-10
0
3
2022-11
0
2.71
2022-12
0
3.11
2023-01
0
3.06
2023-02
1
2.89
2023-03
2
4.17
2023-04
0
4.14
2023-05
0
3.68
2023-06
0
2.91
2023-07
0
2.13
2023-08
0
1.92
2023-09
0
2.59
2023-10
0
2.63
2023-11
0
3.15
2023-12
0
3.13
2024-01
0
1.93
2024-02
0
2.05
2024-03
0
2.17
2024-04
0
2.48
2024-05
0
3.88
2024-06
0
3.86
2024-07
0
3.11
2024-08
0
4.32
2024-09
0
2.29
2024-10
0
2.6
2024-11
0
2.8
2024-12
0
3.03
2025-01
0
6.24
2025-02
0
3.42
2025-03
0
3.26
2025-04
0
5.18
2025-05
0
2.36
2025-06
0
5.9
2025-07
0
3.04
2025-08
1
3.83
2025-09
0
3.96
2025-10
0
4.8
2025-11
0
4.36
2025-12
1
4.88
2026-01
0
4
2026-02
0
8.59
2026-03
0
3.76
2026-04
0
3.72
2026-05
0
4.75
2026-06
0
2.73
This device (reports/month)Average device in FCG, KTI (reports/device/month)
Failure-mode summaryAI-generated
10 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
Date
Report #
Type
Narrative
Link basis
2025-12-26
9614641-2025-02144
Malfunction
Available
exact di
2025-08-18
9614641-2025-01389
Malfunction
Available
exact di
2023-03-24
2429304-2023-00049
Injury
Available
exact di
2023-03-24
9614641-2023-00424
Injury
Available
exact di
2023-02-08
9614641-2023-00185
Injury
Available
exact di
2022-06-01
2951238-2022-00414
Injury
Available
exact di
2022-06-01
8010047-2022-09179
Injury
Available
exact di
2021-02-11
8010047-2021-02526
Malfunction
Available
model number
Showing the most recent 8 of 10 linked reports.
Regulatory clearances
510(k)K190239Substantially equivalent (SESE) · 2019-12-10clearance family
510(k)K180668Substantially equivalent (SESE) · 2018-11-15clearance 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.