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.
2 linked reportsInjury 1Malfunction 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
4.13
2019-02
0
2.1
2019-03
0
2.9
2019-04
0
3
2019-05
0
2.86
2019-06
0
2.59
2019-07
0
3.24
2019-08
0
2.96
2019-09
0
3.2
2019-10
0
3.04
2019-11
0
4.34
2019-12
1
4.49
2020-01
0
4.46
2020-02
0
3.89
2020-03
0
3.58
2020-04
0
4.87
2020-05
0
3.38
2020-06
0
3.53
2020-07
0
3.27
2020-08
0
3.89
2020-09
0
3.62
2020-10
0
4.03
2020-11
0
5.44
2020-12
0
4.74
2021-01
0
3.99
2021-02
0
3.69
2021-03
0
3.53
2021-04
0
3.41
2021-05
0
3.89
2021-06
0
3.83
2021-07
0
3.6
2021-08
0
3.87
2021-09
0
3.87
2021-10
0
3.99
2021-11
0
4.2
2021-12
0
4.04
2022-01
0
3.82
2022-02
0
3.26
2022-03
0
3.71
2022-04
0
3.61
2022-05
0
3.65
2022-06
0
3.53
2022-07
0
3.37
2022-08
0
4.16
2022-09
0
3.66
2022-10
0
4.25
2022-11
0
2.78
2022-12
0
3.64
2023-01
0
3.47
2023-02
0
3.05
2023-03
0
3.7
2023-04
0
4.01
2023-05
0
4.38
2023-06
0
4.35
2023-07
0
3.52
2023-08
0
4.08
2023-09
0
4.3
2023-10
0
4.29
2023-11
0
4.33
2023-12
0
5.06
2024-01
0
5.15
2024-02
0
4.52
2024-03
0
4.4
2024-04
0
4.78
2024-05
0
5.85
2024-06
0
6.97
2024-07
0
3.86
2024-08
0
4.14
2024-09
0
4.74
2024-10
0
4.36
2024-11
0
4.26
2024-12
0
4.11
2025-01
0
4.98
2025-02
0
4.47
2025-03
0
4.27
2025-04
0
4.65
2025-05
0
5.22
2025-06
0
5.06
2025-07
0
4.88
2025-08
0
4.82
2025-09
0
4.25
2025-10
0
4.53
2025-11
0
5.05
2025-12
0
5.73
2026-01
1
4.89
2026-02
0
5.3
2026-03
0
5.66
2026-04
0
5.42
2026-05
0
6.15
2026-06
0
5.99
This device (reports/month)Average device in JDR, MBI (reports/device/month)
Failure-mode summaryAI-generated
2 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
Date
Report #
Type
Narrative
Link basis
2026-01-06
0001825034-2026-00072
Malfunction
Available
exact di
2019-12-06
0001825034-2019-05482
Injury
Available
exact di
Regulatory clearances
510(k)K173278Substantially equivalent (SESE) · 2018-01-05clearance 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.