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.
145 linked reportsInjury 135Malfunction 10
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
5
1.71
2019-02
5
1.54
2019-03
5
1.66
2019-04
0
1.53
2019-05
2
1.78
2019-06
3
1.84
2019-07
1
1.38
2019-08
2
1.99
2019-09
2
1.51
2019-10
1
1.76
2019-11
3
1.63
2019-12
3
1.72
2020-01
1
1.95
2020-02
2
2.16
2020-03
1
1.64
2020-04
0
1.7
2020-05
1
1.51
2020-06
3
1.83
2020-07
3
1.94
2020-08
3
1.73
2020-09
1
1.95
2020-10
4
2
2020-11
0
1.83
2020-12
2
1.79
2021-01
0
1.93
2021-02
0
1.92
2021-03
6
2.02
2021-04
1
1.87
2021-05
1
1.78
2021-06
0
1.58
2021-07
2
1.92
2021-08
1
2.1
2021-09
0
1.74
2021-10
1
1.82
2021-11
3
1.99
2021-12
2
1.92
2022-01
1
2.14
2022-02
0
2.1
2022-03
0
1.77
2022-04
1
2.07
2022-05
4
1.93
2022-06
1
2.03
2022-07
2
2.15
2022-08
2
1.98
2022-09
1
1.88
2022-10
3
1.87
2022-11
2
1.93
2022-12
3
1.81
2023-01
2
1.75
2023-02
0
1.83
2023-03
0
1.96
2023-04
1
1.94
2023-05
2
2.01
2023-06
1
2.21
2023-07
0
2
2023-08
1
1.61
2023-09
1
1.44
2023-10
1
1.57
2023-11
2
1.56
2023-12
1
1.39
2024-01
2
1.81
2024-02
1
1.64
2024-03
1
1.59
2024-04
2
1.74
2024-05
0
1.59
2024-06
1
1.88
2024-07
1
1.5
2024-08
2
1.68
2024-09
0
1.61
2024-10
3
1.59
2024-11
0
1.51
2024-12
2
1.55
2025-01
2
1.67
2025-02
3
1.52
2025-03
2
1.78
2025-04
0
1.58
2025-05
2
1.66
2025-06
2
1.76
2025-07
2
1.66
2025-08
2
1.51
2025-09
0
1.48
2025-10
2
1.56
2025-11
1
1.74
2025-12
2
2.08
2026-01
3
1.81
2026-02
0
1.79
2026-03
0
1.66
2026-04
2
1.69
2026-05
2
1.65
2026-06
1
1.68
This device (reports/month)Average device in HSD, 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
2026-06-18
1818910-2026-10376
Injury
Available
exact di
2026-05-27
1818910-2026-09276
Injury
Available
exact di
2026-05-13
1818910-2026-08660
Malfunction
Available
exact di
2026-04-13
1818910-2026-06666
Injury
Available
exact di
2026-04-09
1818910-2026-06515
Injury
Available
exact di
2026-01-30
1818910-2026-02026
Injury
Available
exact di
2026-01-29
1818910-2026-01917
Injury
Available
exact di
2026-01-20
1818910-2026-01160
Injury
Available
exact di
2025-12-16
1818910-2025-21996
Injury
Available
exact di
2025-12-02
1818910-2025-20948
Injury
Available
exact di
2025-11-25
1818910-2025-20703
Injury
Available
exact di
2025-10-23
1818910-2025-18159
Injury
Available
exact di
2025-10-16
1818910-2025-17661
Injury
Available
exact di
2025-08-19
1818910-2025-14459
Injury
Available
exact di
2025-08-14
1818910-2025-14218
Injury
Available
exact di
Showing the most recent 144 of 145 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.