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.
955 linked reportsMalfunction 931Injury 22Death 2
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
4
2.72
2019-02
0
1.42
2019-03
2
1.87
2019-04
1
1.59
2019-05
0
1.83
2019-06
2
2.25
2019-07
2
1.7
2019-08
0
1.82
2019-09
1
1.33
2019-10
1
1.73
2019-11
1
1.62
2019-12
2
1.55
2020-01
0
2.15
2020-02
0
2.04
2020-03
0
2.27
2020-04
2
1.85
2020-05
3
2.04
2020-06
4
2.57
2020-07
1
2.06
2020-08
0
2.46
2020-09
0
1.77
2020-10
1
1.8
2020-11
3
2.03
2020-12
1
1.76
2021-01
2
1.72
2021-02
2
1.96
2021-03
0
2.45
2021-04
1
1.42
2021-05
1
2.07
2021-06
3
1.8
2021-07
3
1.46
2021-08
2
2.35
2021-09
2
1.61
2021-10
2
2.02
2021-11
5
1.39
2021-12
1
1.57
2022-01
2
1.52
2022-02
1
1.84
2022-03
8
1.94
2022-04
3
1.87
2022-05
1
1.48
2022-06
5
2.5
2022-07
2
2.15
2022-08
5
2.33
2022-09
3
1.6
2022-10
2
2
2022-11
9
2.67
2022-12
5
1.93
2023-01
6
1.97
2023-02
8
1.86
2023-03
6
2.08
2023-04
12
2.74
2023-05
13
2.62
2023-06
13
2.3
2023-07
14
2.89
2023-08
19
3.19
2023-09
8
2.2
2023-10
16
3.18
2023-11
12
2.61
2023-12
19
2.51
2024-01
14
2.76
2024-02
14
2.83
2024-03
8
2.19
2024-04
22
2.67
2024-05
6
2.2
2024-06
7
2.25
2024-07
16
2.71
2024-08
13
2.29
2024-09
25
3.26
2024-10
16
2.97
2024-11
26
3.29
2024-12
14
2.92
2025-01
33
3.7
2025-02
9
2.19
2025-03
15
3.13
2025-04
14
2.69
2025-05
18
2.77
2025-06
35
3.5
2025-07
30
3.83
2025-08
40
3.96
2025-09
16
3.06
2025-10
15
2.76
2025-11
43
4.02
2025-12
42
3.2
2026-01
60
5.19
2026-02
29
3.49
2026-03
35
3.77
2026-04
27
3.08
2026-05
23
3.34
2026-06
43
4.18
This device (reports/month)Average device in KRA, QJP (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
3008114965-2026-00917
Malfunction
—
exact di
2026-06-30
3008114965-2026-00920
Malfunction
—
exact di
2026-06-30
3008114965-2026-00921
Malfunction
—
exact di
2026-06-30
3008114965-2026-00913
Malfunction
—
exact di
2026-06-29
3008114965-2026-00882
Malfunction
—
exact di
2026-06-29
3008114965-2026-00911
Malfunction
—
exact di
2026-06-29
3008114965-2026-00889
Malfunction
—
exact di
2026-06-29
3008114965-2026-00909
Malfunction
—
exact di
2026-06-22
3008114965-2026-00880
Malfunction
—
exact di
2026-06-22
3008114965-2026-00802
Malfunction
—
exact di
2026-06-19
3008114965-2026-00877
Malfunction
—
exact di
2026-06-19
3008114965-2026-00873
Malfunction
—
exact di
2026-06-18
3008114965-2026-00865
Malfunction
Available
exact di
2026-06-18
3008114965-2026-00863
Malfunction
Available
exact di
2026-06-18
3008114965-2026-00871
Malfunction
Available
exact di
Showing the most recent 200 of 955 linked reports.
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.