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
6.59
2019-02
0
4.2
2019-03
0
4.34
2019-04
0
5.92
2019-05
0
4.77
2019-06
0
5.02
2019-07
0
5.82
2019-08
0
6.04
2019-09
0
4.89
2019-10
0
5.84
2019-11
0
5.59
2019-12
0
5.39
2020-01
0
4.7
2020-02
0
5.52
2020-03
0
5.63
2020-04
0
3.53
2020-05
0
3.72
2020-06
0
5.06
2020-07
0
6.41
2020-08
0
4.57
2020-09
0
5.73
2020-10
0
5.39
2020-11
0
5.11
2020-12
0
5.27
2021-01
0
5.11
2021-02
0
4.87
2021-03
0
5.59
2021-04
0
5.17
2021-05
0
5.01
2021-06
0
5.63
2021-07
0
4.85
2021-08
0
4.32
2021-09
0
4.71
2021-10
0
6.02
2021-11
0
5.45
2021-12
0
5.49
2022-01
0
5.03
2022-02
0
5.14
2022-03
0
5.73
2022-04
0
4.88
2022-05
0
5.81
2022-06
0
6.16
2022-07
0
4.2
2022-08
0
4.56
2022-09
0
4.83
2022-10
0
4.66
2022-11
0
4.59
2022-12
0
4.02
2023-01
0
5.52
2023-02
0
4.61
2023-03
1
4.85
2023-04
0
4.74
2023-05
0
5.15
2023-06
0
4.77
2023-07
0
4.85
2023-08
0
4.36
2023-09
0
5.12
2023-10
0
5.05
2023-11
0
4.35
2023-12
0
4.76
2024-01
0
5.4
2024-02
0
5.37
2024-03
0
6.06
2024-04
0
5.91
2024-05
0
6.12
2024-06
0
5.37
2024-07
0
4.94
2024-08
0
4.91
2024-09
0
5.21
2024-10
0
5.58
2024-11
0
5.19
2024-12
0
4.02
2025-01
0
5.09
2025-02
0
4.34
2025-03
0
6.18
2025-04
0
4.32
2025-05
0
4.93
2025-06
0
4.93
2025-07
0
5.04
2025-08
0
5.24
2025-09
0
4.72
2025-10
0
5
2025-11
0
5.36
2025-12
0
5.53
2026-01
0
5.43
2026-02
0
5.78
2026-03
0
5.95
2026-04
0
5.24
2026-05
0
5.83
2026-06
0
5.5
This device (reports/month)Average device in FAS, FDC, GEI (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
2023-03-15
MW5115776
Malfunction
Available
catalog number
Regulatory clearances
510(k)K213135Substantially equivalent (SESE) · 2022-03-02clearance 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.