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
2.42
2019-02
0
3.53
2019-03
0
2.95
2019-04
0
3.13
2019-05
0
2.46
2019-06
0
3.58
2019-07
0
2.42
2019-08
0
2.47
2019-09
0
2.47
2019-10
0
2.71
2019-11
0
2.12
2019-12
0
2.35
2020-01
0
2.55
2020-02
0
2.7
2020-03
0
2.28
2020-04
0
2.54
2020-05
0
1.98
2020-06
0
2.78
2020-07
0
2.77
2020-08
0
4.33
2020-09
0
4.4
2020-10
0
3.99
2020-11
0
4.47
2020-12
0
3.87
2021-01
0
3.99
2021-02
0
3.89
2021-03
0
4.83
2021-04
0
4.7
2021-05
0
4.05
2021-06
0
4.28
2021-07
0
3.88
2021-08
3
3.87
2021-09
0
3.91
2021-10
0
3.99
2021-11
0
3.49
2021-12
0
4.46
2022-01
0
4.57
2022-02
0
5.03
2022-03
0
5.45
2022-04
0
6.48
2022-05
0
5.46
2022-06
0
6.07
2022-07
0
6.34
2022-08
0
6.38
2022-09
0
5.53
2022-10
0
5.35
2022-11
0
5.52
2022-12
0
6
2023-01
0
5.73
2023-02
0
4.87
2023-03
0
5.86
2023-04
0
5.47
2023-05
0
5.86
2023-06
0
7.1
2023-07
0
6.1
2023-08
0
6.28
2023-09
0
5.92
2023-10
0
6.38
2023-11
0
5.76
2023-12
0
6.05
2024-01
0
5.53
2024-02
0
6.18
2024-03
0
5.56
2024-04
0
6.32
2024-05
0
5.3
2024-06
0
7.07
2024-07
0
5.75
2024-08
0
6.5
2024-09
0
6.28
2024-10
0
7.11
2024-11
0
4.55
2024-12
0
4.77
2025-01
0
4.42
2025-02
0
4.03
2025-03
0
5.17
2025-04
0
4.67
2025-05
0
4.69
2025-06
0
4.58
2025-07
0
4.68
2025-08
0
5.45
2025-09
0
3.97
2025-10
0
4.59
2025-11
0
4.86
2025-12
0
6.15
2026-01
0
4.95
2026-02
0
5.05
2026-03
0
5.77
2026-04
0
6.2
2026-05
0
5.86
2026-06
0
5.01
This device (reports/month)Average device in GCJ (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
2021-08-27
MW5103570
Malfunction
Available
catalog number
2021-08-20
MW5103405
Malfunction
Available
exact di
Showing the most recent 2 of 3 linked reports.
Regulatory clearances
510(k)K182080Substantially equivalent (SESE) · 2018-09-19clearance 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.