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.
35 linked reportsMalfunction 26Injury 9
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
2019-02
0
2.58
2019-03
0
3.29
2019-04
0
4
2019-05
0
2.2
2019-06
0
5
2019-07
0
4.59
2019-08
0
3.42
2019-09
0
2.33
2019-10
0
3.5
2019-11
0
2.93
2019-12
0
4.27
2020-01
0
3.67
2020-02
0
4
2020-03
0
3.88
2020-04
0
3.27
2020-05
0
2.71
2020-06
0
5
2020-07
0
2.05
2020-08
0
2.67
2020-09
0
2.62
2020-10
0
4
2020-11
0
3.31
2020-12
0
4.33
2021-01
0
2.25
2021-02
1
4.14
2021-03
0
3.44
2021-04
0
3.8
2021-05
0
2.69
2021-06
0
6.18
2021-07
0
8
2021-08
1
4.26
2021-09
0
4.29
2021-10
0
5.75
2021-11
0
4.21
2021-12
0
5.58
2022-01
1
4.76
2022-02
0
3.06
2022-03
0
6.19
2022-04
0
4.15
2022-05
0
5
2022-06
2
2.13
2022-07
0
3.87
2022-08
0
3.42
2022-09
0
3.15
2022-10
0
3
2022-11
0
3.89
2022-12
1
11.2
2023-01
0
20.62
2023-02
0
9.35
2023-03
0
12.22
2023-04
0
13.21
2023-05
0
18.4
2023-06
0
18.95
2023-07
0
11.93
2023-08
0
11.5
2023-09
1
10.06
2023-10
0
10.82
2023-11
2
9.45
2023-12
0
11.69
2024-01
0
9.13
2024-02
0
11.61
2024-03
0
12.31
2024-04
2
10.69
2024-05
1
12.26
2024-06
1
9.57
2024-07
0
10.33
2024-08
0
11.61
2024-09
0
13.31
2024-10
1
10.49
2024-11
0
8.09
2024-12
0
12.53
2025-01
1
11.32
2025-02
1
12.94
2025-03
1
9.6
2025-04
3
10.36
2025-05
1
9.76
2025-06
5
9.05
2025-07
1
9.3
2025-08
2
9.82
2025-09
1
9.47
2025-10
0
8.89
2025-11
0
9.82
2025-12
2
9.93
2026-01
0
12.47
2026-02
0
17.64
2026-03
0
8.42
2026-04
0
8.76
2026-05
2
6.15
2026-06
1
8.38
This device (reports/month)Average device in HIH (reports/device/month)
Failure-mode summaryAI-generated
34 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
Date
Report #
Type
Narrative
Link basis
2026-06-26
0001056128-2026-00041
Malfunction
—
exact di
2026-05-06
0001056128-2026-00032
Injury
Available
exact di
2026-05-06
0001056128-2026-00031
Injury
Available
exact di
2025-12-19
0001056128-2025-00093
Malfunction
Available
exact di
2025-12-02
0001056128-2025-00085
Malfunction
Available
exact di
2025-09-24
0001056128-2025-00061
Malfunction
Available
exact di
2025-08-20
22849167
Malfunction
Available
catalog number
2025-07-29
0001056128-2025-00051
Injury
Available
exact di
2025-06-30
22352630
Malfunction
Available
catalog number
2025-06-25
0001056128-2025-00045
Malfunction
Available
exact di
2025-06-19
0001056128-2025-00043
Injury
Available
exact di
2025-06-19
0001056128-2025-00044
Injury
Available
exact di
2025-05-23
0001056128-2025-00039
Malfunction
Available
exact di
2025-04-25
0001056128-2025-00037
Malfunction
Available
exact di
2025-04-03
0001056128-2025-00024
Malfunction
Available
exact di
Showing the most recent 33 of 35 linked reports.
Showing 1–15 of 33
Regulatory clearances
510(k)K201756Substantially equivalent (SESE) · 2020-09-25clearance 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.