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.
1 linked reportMalfunction 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
0
2.75
2019-02
0
2.3
2019-03
0
5.36
2019-04
0
14.54
2019-05
0
3.75
2019-06
0
3.29
2019-07
0
3.88
2019-08
0
3.18
2019-09
0
2.82
2019-10
0
3.07
2019-11
0
3.18
2019-12
0
3.15
2020-01
0
2.66
2020-02
0
4.9
2020-03
0
2.9
2020-04
0
3.15
2020-05
0
4.63
2020-06
0
3.89
2020-07
0
6.27
2020-08
0
5.11
2020-09
0
5.23
2020-10
0
6.26
2020-11
0
6.22
2020-12
0
8.65
2021-01
0
7.78
2021-02
0
8.18
2021-03
0
9.67
2021-04
0
8.73
2021-05
0
8.62
2021-06
0
7.11
2021-07
0
7.3
2021-08
0
8.09
2021-09
0
9.86
2021-10
0
7.81
2021-11
0
8.29
2021-12
0
10.19
2022-01
0
8.75
2022-02
0
9.93
2022-03
0
11.47
2022-04
0
11.8
2022-05
0
11.06
2022-06
0
11.83
2022-07
0
10.72
2022-08
0
10.57
2022-09
0
10.16
2022-10
0
10.37
2022-11
0
9.6
2022-12
0
10.16
2023-01
0
9.57
2023-02
0
9.15
2023-03
0
12.08
2023-04
0
11.05
2023-05
0
9.98
2023-06
0
9.59
2023-07
0
10.36
2023-08
0
11.81
2023-09
0
10.64
2023-10
0
11.52
2023-11
0
12.14
2023-12
0
11.08
2024-01
0
11.09
2024-02
0
12.05
2024-03
0
13.64
2024-04
0
11.66
2024-05
0
10.81
2024-06
0
12.09
2024-07
0
12.32
2024-08
0
10.89
2024-09
0
11.11
2024-10
0
13.81
2024-11
0
8.99
2024-12
0
6.55
2025-01
0
7.04
2025-02
0
6.15
2025-03
0
7.27
2025-04
0
7.83
2025-05
0
7.92
2025-06
0
8.14
2025-07
0
8.21
2025-08
0
8.91
2025-09
0
6.24
2025-10
0
10.66
2025-11
0
17.02
2025-12
0
32.32
2026-01
0
25.72
2026-02
1
15.54
2026-03
0
15.16
2026-04
0
21.35
2026-05
0
21.97
2026-06
0
21.39
This device (reports/month)Average device in EOB, EOQ, FDF, FDS, FET, NTN, NWB (reports/device/month)
Failure-mode summaryAI-generated
1 linked report narrative available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
Date
Report #
Type
Narrative
Link basis
2026-02-11
3002808148-2026-03984
Malfunction
Available
exact di
Regulatory clearances
510(k)K222861Substantially equivalent (SESE) · 2023-06-15clearance 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.