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.
18 linked reportsInjury 12Malfunction 6
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
11.67
2019-02
0
6.78
2019-03
0
6.4
2019-04
0
3.14
2019-05
0
9.67
2019-06
0
3.67
2019-07
0
10.88
2019-08
0
3.69
2019-09
0
3.11
2019-10
0
3.6
2019-11
0
9.88
2019-12
0
10.5
2020-01
0
5.71
2020-02
0
7
2020-03
0
5.73
2020-04
0
4.3
2020-05
0
7.18
2020-06
0
5.58
2020-07
0
21.75
2020-08
0
8.25
2020-09
0
12
2020-10
0
9.94
2020-11
0
8.83
2020-12
0
12.31
2021-01
0
11.36
2021-02
0
10.08
2021-03
0
22.15
2021-04
0
13.38
2021-05
0
11.4
2021-06
0
10.94
2021-07
0
9.67
2021-08
0
10.79
2021-09
0
21.62
2021-10
0
14
2021-11
12
16.56
2021-12
6
23.23
2022-01
0
13.83
2022-02
0
22.91
2022-03
0
19.31
2022-04
0
19.44
2022-05
0
20.14
2022-06
0
21.15
2022-07
0
9.47
2022-08
0
8.94
2022-09
0
11.92
2022-10
0
16.57
2022-11
0
8.47
2022-12
0
11.77
2023-01
0
12.55
2023-02
0
14.08
2023-03
0
9.86
2023-04
0
9.38
2023-05
0
14.62
2023-06
0
12.82
2023-07
0
12.08
2023-08
0
14.14
2023-09
0
12.89
2023-10
0
19.92
2023-11
0
16.71
2023-12
0
15.31
2024-01
0
25.36
2024-02
0
17.08
2024-03
0
17.67
2024-04
0
13.13
2024-05
0
15.2
2024-06
0
16.67
2024-07
0
9.31
2024-08
0
10.77
2024-09
0
10.6
2024-10
0
17.42
2024-11
0
8.27
2024-12
0
2.55
2025-01
0
5.4
2025-02
0
3.4
2025-03
0
6.21
2025-04
0
5.18
2025-05
0
6.43
2025-06
0
7.42
2025-07
0
7.36
2025-08
0
8.67
2025-09
0
7.86
2025-10
0
10.83
2025-11
0
15.08
2025-12
0
22.64
2026-01
0
32.46
2026-02
0
16
2026-03
0
16.73
2026-04
0
29.85
2026-05
0
50.73
2026-06
0
33.29
This device (reports/month)Average device in FDT (reports/device/month)
Failure-mode summaryAI-generated
18 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
Date
Report #
Type
Narrative
Link basis
2021-12-02
9610691-2021-00018
Injury
Available
catalog number
2021-12-02
1220828-2021-00020
Injury
Available
catalog number
2021-11-29
9610691-2021-00017
Injury
Available
catalog number
2021-11-29
1220828-2021-00019
Injury
Available
catalog number
2021-11-04
9610691-2021-00016
Malfunction
Available
catalog number
2021-11-04
1220828-2021-00018
Malfunction
Available
catalog number
Showing the most recent 6 of 18 linked reports.
Regulatory clearances
510(k)K201098Substantially equivalent (SESE) · 2020-07-17clearance 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.