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.
213 linked reportsInjury 203Malfunction 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
0
1.82
2019-02
0
1.85
2019-03
0
1.75
2019-04
0
1.88
2019-05
0
2.1
2019-06
0
1.88
2019-07
0
1.68
2019-08
0
2.18
2019-09
1
1.67
2019-10
1
1.88
2019-11
0
1.72
2019-12
0
1.77
2020-01
1
1.96
2020-02
0
2.08
2020-03
0
2.19
2020-04
0
1.8
2020-05
0
1.66
2020-06
0
1.95
2020-07
0
2.24
2020-08
0
1.76
2020-09
0
1.96
2020-10
0
2.2
2020-11
0
1.9
2020-12
0
1.87
2021-01
0
2.2
2021-02
2
1.99
2021-03
0
2.15
2021-04
0
2.02
2021-05
0
2.02
2021-06
0
1.91
2021-07
0
2.06
2021-08
2
2.19
2021-09
0
1.97
2021-10
0
2.18
2021-11
0
2.13
2021-12
0
2.6
2022-01
0
2.65
2022-02
2
2.35
2022-03
0
2.51
2022-04
0
2.48
2022-05
0
2.13
2022-06
0
2.24
2022-07
0
2.2
2022-08
0
2.27
2022-09
0
2.04
2022-10
3
2.12
2022-11
3
2.16
2022-12
0
2.1
2023-01
1
1.85
2023-02
4
2.06
2023-03
1
2.05
2023-04
6
2.22
2023-05
12
2.12
2023-06
10
2.32
2023-07
0
2.11
2023-08
10
1.76
2023-09
2
1.59
2023-10
4
1.64
2023-11
0
1.69
2023-12
2
1.46
2024-01
4
1.9
2024-02
6
1.89
2024-03
2
1.73
2024-04
2
1.87
2024-05
0
1.72
2024-06
0
1.89
2024-07
4
1.63
2024-08
4
1.73
2024-09
0
1.74
2024-10
2
1.73
2024-11
1
1.64
2024-12
4
1.67
2025-01
2
1.74
2025-02
2
1.65
2025-03
10
1.94
2025-04
10
1.73
2025-05
10
1.83
2025-06
9
1.96
2025-07
8
1.8
2025-08
2
1.61
2025-09
2
1.52
2025-10
5
1.69
2025-11
0
1.74
2025-12
6
2.19
2026-01
14
1.93
2026-02
10
1.85
2026-03
15
1.8
2026-04
4
1.74
2026-05
4
1.8
2026-06
4
1.8
This device (reports/month)Average device in KWS, PHX (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
2026-06-09
0001649390-2026-00538
Injury
Available
catalog number
2026-06-05
0001649390-2026-00530
Injury
Available
catalog number
2026-05-29
0001649390-2026-00520
Injury
Available
catalog number
2026-05-15
0001649390-2026-00434
Injury
Available
catalog number
2026-04-29
0001649390-2026-00386
Injury
Available
catalog number
2026-04-28
0001649390-2026-00382
Injury
Available
catalog number
2026-03-23
0001649390-2026-00300
Injury
Available
catalog number
2026-03-19
0001649390-2026-00288
Injury
Available
catalog number
2026-03-10
0001649390-2026-00251
Injury
Available
catalog number
2026-03-10
0001649390-2026-00250
Injury
Available
catalog number
2026-03-05
0001649390-2026-00229
Injury
Available
catalog number
2026-03-05
0001649390-2026-00224
Injury
Available
catalog number
2026-03-03
0001649390-2026-00213
Injury
Available
catalog number
2026-03-03
0001649390-2026-00214
Injury
Available
catalog number
2026-02-24
0001649390-2026-00194
Injury
Available
catalog number
Showing the most recent 109 of 213 linked reports.