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.
408 linked reportsMalfunction 380Injury 28
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
4.67
2019-02
0
2.34
2019-03
0
3.13
2019-04
0
3.17
2019-05
0
3.26
2019-06
0
2.82
2019-07
0
3.81
2019-08
0
3.49
2019-09
0
3.35
2019-10
4
3.19
2019-11
8
5.28
2019-12
11
5.45
2020-01
4
5.46
2020-02
0
4.5
2020-03
0
3.98
2020-04
0
5.42
2020-05
0
3.88
2020-06
2
3.71
2020-07
0
3.74
2020-08
2
4.23
2020-09
0
4.05
2020-10
1
4.53
2020-11
0
6.39
2020-12
0
5.41
2021-01
0
4.74
2021-02
2
3.95
2021-03
9
3.83
2021-04
5
3.82
2021-05
3
4.06
2021-06
1
4.11
2021-07
1
4
2021-08
3
4.46
2021-09
1
4.05
2021-10
1
4.44
2021-11
3
4.37
2021-12
1
4.43
2022-01
1
4
2022-02
4
3.37
2022-03
2
3.88
2022-04
1
3.8
2022-05
2
4.06
2022-06
2
3.85
2022-07
0
3.56
2022-08
5
4.39
2022-09
3
3.86
2022-10
1
4.15
2022-11
2
2.87
2022-12
2
3.93
2023-01
2
3.27
2023-02
3
3.2
2023-03
13
3.8
2023-04
12
4.26
2023-05
5
4.67
2023-06
14
4.2
2023-07
6
3.85
2023-08
10
4.49
2023-09
12
4.47
2023-10
10
4.71
2023-11
13
4.63
2023-12
8
5.49
2024-01
8
5.56
2024-02
2
4.93
2024-03
18
4.78
2024-04
9
5.43
2024-05
6
6.48
2024-06
4
7.52
2024-07
3
4.11
2024-08
0
4.21
2024-09
8
5
2024-10
9
4.7
2024-11
9
4.41
2024-12
10
4.25
2025-01
4
5.12
2025-02
6
4.81
2025-03
12
4.57
2025-04
7
4.98
2025-05
11
5.81
2025-06
14
5.47
2025-07
10
5.19
2025-08
11
5.08
2025-09
5
4.29
2025-10
8
4.62
2025-11
10
5.25
2025-12
9
6.07
2026-01
5
5.06
2026-02
5
5.39
2026-03
1
5.98
2026-04
2
5.93
2026-05
3
5.88
2026-06
4
6.16
This device (reports/month)Average device in MBI (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
2026-06-30
0001825034-2026-01938
Malfunction
Available
exact di
2026-06-29
0001825034-2026-01926
Injury
Available
exact di
2026-06-03
0001825034-2026-01586
Malfunction
Available
exact di
2026-06-02
0001825034-2026-01579
Malfunction
Available
exact di
2026-05-15
0001825034-2026-01315
Malfunction
Available
exact di
2026-05-08
0001825034-2026-01238
Malfunction
Available
exact di
2026-05-07
0001825034-2026-01236
Malfunction
Available
exact di
2026-04-15
0001825034-2026-00956
Malfunction
Available
exact di
2026-04-07
0001825034-2026-00857
Malfunction
Available
exact di
2026-03-17
0001825034-2026-00611
Malfunction
Available
exact di
2026-02-20
0001825034-2026-00399
Malfunction
Available
exact di
2026-02-18
0001825034-2026-00377
Malfunction
Available
exact di
2026-02-10
0001825034-2026-00316
Malfunction
Available
exact di
2026-02-09
0001825034-2026-00305
Malfunction
Available
exact di
2026-02-03
0001825034-2026-00279
Malfunction
Available
exact di
Showing the most recent 200 of 408 linked reports.
Showing 1–15 of 200
Regulatory clearances
510(k)K191459Substantially equivalent (SESE) · 2019-09-13clearance family
510(k)K150424Substantially equivalent (SESE) · 2015-05-15clearance 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.