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.
244 linked reportsMalfunction 237Injury 7
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-02
0
1
2019-04
0
1
2019-05
0
1
2019-06
0
1.33
2019-07
0
1
2019-08
0
1
2019-09
0
1.5
2019-10
0
1
2019-12
0
1.5
2020-01
0
1
2020-02
0
1
2020-03
0
1.4
2020-04
0
1.4
2020-05
0
1
2020-06
0
1
2020-07
0
4.5
2020-08
0
2
2020-09
0
3
2020-10
0
4.5
2020-11
0
1
2020-12
0
2
2021-01
0
3.14
2021-03
0
2.75
2021-04
0
1.33
2021-05
2
3.14
2021-06
1
3.67
2021-07
0
2
2021-08
0
3.25
2021-09
0
1.8
2021-10
4
4
2021-11
0
4.5
2021-12
0
3
2022-01
0
1
2022-02
5
2.5
2022-03
0
2.75
2022-04
0
1
2022-05
0
2.33
2022-06
0
2.5
2022-07
0
2.17
2022-08
0
2.29
2022-09
0
2.86
2022-10
0
3.25
2022-11
0
2.5
2022-12
0
3.4
2023-01
0
2
2023-02
0
2
2023-03
0
1.5
2023-05
3
2.5
2023-06
0
1
2023-07
0
1.5
2023-08
0
2.2
2023-09
0
2
2023-10
0
1.67
2023-11
0
1.67
2023-12
0
2.33
2024-01
0
1.33
2024-02
0
1.67
2024-03
0
3.25
2024-04
0
3
2024-05
0
2
2024-06
4
2.25
2024-08
0
1.6
2024-09
2
1.75
2024-10
4
2.33
2024-11
13
5.67
2024-12
24
8.67
2025-01
6
2.6
2025-02
16
7
2025-03
10
5.33
2025-04
14
4.25
2025-05
8
3.33
2025-06
8
5
2025-07
2
2
2025-08
4
1.83
2025-09
12
3.17
2025-10
11
2.44
2025-11
12
3.8
2025-12
10
4.33
2026-01
2
1.5
2026-02
8
3.8
2026-03
10
2.8
2026-04
9
4
2026-05
32
17
2026-06
8
2
This device (reports/month)Average device in GFG (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
2026-06-15
0001649390-2026-00554
Malfunction
Available
catalog number
2026-06-09
0001649390-2026-00541
Injury
Available
catalog number
2026-06-09
0001649390-2026-00540
Malfunction
Available
catalog number
2026-06-02
0001649390-2026-00525
Malfunction
Available
catalog number
2026-05-22
0001649390-2026-00490
Malfunction
Available
catalog number
2026-05-22
0001649390-2026-00491
Malfunction
Available
catalog number
2026-05-21
0001649390-2026-00488
Malfunction
Available
catalog number
2026-05-13
0001649390-2026-00428
Malfunction
Available
catalog number
2026-05-12
0001649390-2026-00416
Malfunction
Available
catalog number
2026-05-12
0001649390-2026-00420
Malfunction
Available
catalog number
2026-05-12
0001649390-2026-00419
Malfunction
Available
catalog number
2026-05-12
0001649390-2026-00422
Malfunction
Available
catalog number
2026-05-12
0001649390-2026-00418
Malfunction
Available
catalog number
2026-05-12
0001649390-2026-00421
Malfunction
Available
catalog number
2026-05-12
0001649390-2026-00417
Malfunction
Available
catalog number
Showing the most recent 129 of 244 linked reports.