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.
888 linked reportsMalfunction 884Injury 4
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
4.57
2019-02
1
2.6
2019-03
0
3.45
2019-04
3
3.33
2019-05
5
3.15
2019-06
0
3.11
2019-07
4
3.62
2019-08
0
3.74
2019-09
4
3.92
2019-10
5
3.72
2019-11
6
4.59
2019-12
10
4.75
2020-01
4
4.79
2020-02
2
3.72
2020-03
0
4.43
2020-04
5
5.91
2020-05
0
4.24
2020-06
6
4.29
2020-07
8
4.32
2020-08
1
4.54
2020-09
3
3.97
2020-10
0
4.51
2020-11
4
5.97
2020-12
0
5.53
2021-01
0
5.32
2021-02
2
4.7
2021-03
3
4.81
2021-04
1
5.04
2021-05
2
4.72
2021-06
7
4.26
2021-07
0
4.85
2021-08
3
4.52
2021-09
7
4.68
2021-10
6
4.98
2021-11
1
5.09
2021-12
3
5.04
2022-01
5
4.67
2022-02
3
4.37
2022-03
9
4.86
2022-04
1
4.45
2022-05
3
4.93
2022-06
8
4.22
2022-07
2
4.36
2022-08
12
5.82
2022-09
3
4.68
2022-10
13
5.29
2022-11
6
4.83
2022-12
19
5.4
2023-01
7
5.58
2023-02
3
5.46
2023-03
25
6.1
2023-04
17
6.58
2023-05
7
6.67
2023-06
12
7.12
2023-07
8
6.4
2023-08
5
6.63
2023-09
9
5.65
2023-10
8
6.61
2023-11
10
4.84
2023-12
9
6.41
2024-01
13
5.68
2024-02
2
6.45
2024-03
13
8.97
2024-04
10
13.7
2024-05
17
13.88
2024-06
14
14.96
2024-07
11
13.82
2024-08
17
8.5
2024-09
18
8.31
2024-10
29
6.11
2024-11
17
6.2
2024-12
20
5.48
2025-01
25
5.69
2025-02
17
4.69
2025-03
15
5.06
2025-04
19
5.32
2025-05
20
5.79
2025-06
14
5.63
2025-07
16
5
2025-08
16
5.41
2025-09
10
4.37
2025-10
14
4.79
2025-11
20
6.43
2025-12
20
5.95
2026-01
32
5.86
2026-02
34
6.39
2026-03
22
5.9
2026-04
26
6.05
2026-05
38
6.75
2026-06
34
6.75
This device (reports/month)Average device in GAT, HTY, JDR, MAI, MBI, NEW (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
1221934-2026-02863
Malfunction
—
exact di
2026-06-30
1221934-2026-02855
Malfunction
—
exact di
2026-06-29
1221934-2026-02834
Malfunction
—
exact di
2026-06-29
1221934-2026-02832
Malfunction
—
exact di
2026-06-25
1221934-2026-02791
Malfunction
—
catalog number
2026-06-24
1221934-2026-02731
Malfunction
Available
exact di
2026-06-23
1221934-2026-02742
Malfunction
—
exact di
2026-06-23
1221934-2026-02743
Malfunction
—
exact di
2026-06-19
1221934-2026-02687
Malfunction
Available
exact di
2026-06-18
1221934-2026-02655
Malfunction
Available
exact di
2026-06-18
1221934-2026-02671
Malfunction
Available
exact di
2026-06-18
1221934-2026-02656
Malfunction
Available
exact di
2026-06-18
1221934-2026-02681
Malfunction
Available
exact di
2026-06-17
1221934-2026-02648
Malfunction
Available
exact di
2026-06-16
1221934-2026-02606
Malfunction
Available
exact di
Showing the most recent 200 of 888 linked reports.
Showing 1–15 of 200
Regulatory clearances
510(k)K092836Substantially equivalent (SESE) · 2010-02-04clearance 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.