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.
128 linked reportsInjury 128
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
2
1.68
2019-02
0
1.59
2019-03
0
1.68
2019-04
0
1.52
2019-05
4
1.76
2019-06
6
1.87
2019-07
2
1.41
2019-08
0
1.97
2019-09
0
1.48
2019-10
0
1.8
2019-11
0
1.62
2019-12
1
1.74
2020-01
1
1.89
2020-02
1
2.15
2020-03
1
1.76
2020-04
1
1.72
2020-05
0
1.43
2020-06
0
1.8
2020-07
1
1.91
2020-08
0
1.63
2020-09
2
1.92
2020-10
2
2.1
2020-11
1
1.85
2020-12
0
1.82
2021-01
2
1.95
2021-02
0
1.82
2021-03
1
1.98
2021-04
1
1.76
2021-05
1
1.76
2021-06
0
1.63
2021-07
1
1.87
2021-08
0
2.03
2021-09
0
1.66
2021-10
1
1.71
2021-11
1
1.97
2021-12
2
1.93
2022-01
2
2.04
2022-02
2
2.04
2022-03
0
1.73
2022-04
1
2.04
2022-05
1
1.88
2022-06
1
2.01
2022-07
0
2.05
2022-08
3
2
2022-09
0
1.84
2022-10
2
1.87
2022-11
1
2.02
2022-12
2
1.82
2023-01
2
1.72
2023-02
6
1.94
2023-03
8
1.93
2023-04
0
1.92
2023-05
6
2
2023-06
4
2.26
2023-07
4
2.07
2023-08
1
1.67
2023-09
1
1.51
2023-10
1
1.56
2023-11
2
1.61
2023-12
1
1.41
2024-01
2
1.99
2024-02
0
1.76
2024-03
1
1.68
2024-04
1
1.77
2024-05
1
1.72
2024-06
1
1.9
2024-07
1
1.6
2024-08
2
1.7
2024-09
3
1.71
2024-10
1
1.61
2024-11
2
1.58
2024-12
1
1.63
2025-01
1
1.72
2025-02
1
1.56
2025-03
0
1.84
2025-04
0
1.63
2025-05
5
1.75
2025-06
3
1.83
2025-07
1
1.71
2025-08
1
1.53
2025-09
2
1.51
2025-10
1
1.62
2025-11
2
1.71
2025-12
1
2.11
2026-01
2
1.87
2026-02
1
1.8
2026-03
1
1.75
2026-04
2
1.7
2026-05
1
1.75
2026-06
1
1.68
This device (reports/month)Average device in KWS (reports/device/month)
Failure-mode summaryAI-generated
40 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
Date
Report #
Type
Narrative
Link basis
2026-06-29
1644408-2026-01260
Injury
Available
exact di
2026-05-20
1644408-2026-00961
Injury
Available
exact di
2026-04-09
1644408-2026-00671
Injury
Available
exact di
2026-04-09
1644408-2026-00670
Injury
Available
exact di
2026-03-16
1644408-2026-00453
Injury
Available
exact di
2026-02-17
1644408-2026-00277
Injury
Available
exact di
2026-01-21
1644408-2026-00108
Injury
Available
exact di
2026-01-14
1644408-2026-00072
Injury
Available
exact di
2025-12-02
1644408-2025-01834
Injury
Available
exact di
2025-11-20
1644408-2025-01738
Injury
Available
exact di
2025-11-03
1644408-2025-01638
Injury
Available
exact di
2025-10-23
1644408-2025-01573
Injury
Available
exact di
2025-09-15
1644408-2025-01347
Injury
Available
exact di
2025-09-06
1644408-2025-01282
Injury
Available
exact di
2025-08-13
1644408-2025-01163
Injury
Available
exact di
Showing the most recent 109 of 128 linked reports.
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.