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.
3 linked reportsMalfunction 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
12.29
2019-02
0
14.11
2019-03
0
13.79
2019-04
0
17.85
2019-05
0
19.37
2019-06
0
19.72
2019-07
0
13.34
2019-08
0
11.84
2019-09
0
11.76
2019-10
0
9.56
2019-11
0
11.77
2019-12
0
14.42
2020-01
0
10.77
2020-02
0
12.09
2020-03
0
12.63
2020-04
0
10.79
2020-05
0
14.51
2020-06
0
11.22
2020-07
0
13.17
2020-08
0
11.68
2020-09
0
10.81
2020-10
0
11.91
2020-11
0
12.95
2020-12
0
11.79
2021-01
0
11.04
2021-02
0
12.98
2021-03
0
12.28
2021-04
0
12.01
2021-05
0
13.69
2021-06
0
16.07
2021-07
0
12.52
2021-08
0
14.63
2021-09
0
21.27
2021-10
0
12.6
2021-11
0
14.61
2021-12
0
11.69
2022-01
0
9.82
2022-02
0
11.02
2022-03
0
13.31
2022-04
0
10.99
2022-05
0
14.33
2022-06
0
13.79
2022-07
0
11.32
2022-08
1
12.48
2022-09
0
13.86
2022-10
0
16.25
2022-11
0
14.37
2022-12
0
13.48
2023-01
0
12.02
2023-02
0
11.05
2023-03
0
14.05
2023-04
0
11.93
2023-05
0
13.92
2023-06
0
20.13
2023-07
1
20.36
2023-08
0
19.05
2023-09
0
13.77
2023-10
0
15.56
2023-11
1
15.33
2023-12
0
16.27
2024-01
0
22.02
2024-02
0
17.25
2024-03
0
17.66
2024-04
0
18.36
2024-05
0
14.83
2024-06
0
14.7
2024-07
0
19.11
2024-08
0
25.11
2024-09
0
19.41
2024-10
0
23.57
2024-11
0
13.03
2024-12
0
14.59
2025-01
0
14.46
2025-02
0
19.62
2025-03
0
18.89
2025-04
0
19.25
2025-05
0
16.53
2025-06
0
25.12
2025-07
0
15.88
2025-08
0
14.53
2025-09
0
15.12
2025-10
0
15.97
2025-11
0
13.1
2025-12
0
12.77
2026-01
0
14.05
2026-02
0
11.14
2026-03
0
15.44
2026-04
0
11.76
2026-05
0
13.89
2026-06
0
9.32
This device (reports/month)Average device in HAW, LLZ (reports/device/month)
Failure-mode summaryAI-generated
3 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
Date
Report #
Type
Narrative
Link basis
2023-11-03
1818910-2023-22519
Malfunction
Available
exact di
2023-07-16
1818910-2023-14417
Malfunction
Available
exact di
2022-08-29
1818910-2022-16779
Malfunction
Available
exact di
Regulatory clearances
510(k)K160284Substantially equivalent (SESE) · 2016-08-03clearance 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.