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.
235 linked reportsMalfunction 232Injury 3
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
2.29
2019-02
0
3.68
2019-03
0
4.9
2019-04
0
3.39
2019-05
0
4
2019-06
0
3.65
2019-07
0
3.23
2019-08
0
3.89
2019-09
0
2.94
2019-10
0
3
2019-11
0
3.32
2019-12
0
3.76
2020-01
0
3.19
2020-02
0
6.36
2020-03
0
5.11
2020-04
0
3.12
2020-05
0
2.9
2020-06
0
4.24
2020-07
0
3.8
2020-08
0
3.06
2020-09
0
4.6
2020-10
0
3.78
2020-11
0
4.29
2020-12
0
4.34
2021-01
0
3.3
2021-02
0
3.03
2021-03
0
3.51
2021-04
0
2.92
2021-05
0
2.73
2021-06
0
3.62
2021-07
0
3.29
2021-08
0
4.9
2021-09
0
3.59
2021-10
0
2.88
2021-11
0
3.54
2021-12
0
4.3
2022-01
0
2.93
2022-02
0
3.79
2022-03
0
3.94
2022-04
0
2.55
2022-05
0
3.36
2022-06
0
3.9
2022-07
0
3.02
2022-08
0
3.9
2022-09
0
4.04
2022-10
0
3.41
2022-11
0
3.62
2022-12
0
4.61
2023-01
0
3.21
2023-02
0
3.83
2023-03
0
3.93
2023-04
0
3.25
2023-05
0
4.68
2023-06
0
4.04
2023-07
0
2.9
2023-08
2
3.5
2023-09
0
3.58
2023-10
0
2.62
2023-11
2
4.11
2023-12
0
2.85
2024-01
0
3.18
2024-02
0
3.13
2024-03
0
3.59
2024-04
0
2.68
2024-05
0
2.7
2024-06
0
3.29
2024-07
1
2.6
2024-08
3
2.75
2024-09
6
3.49
2024-10
0
2.67
2024-11
0
2.16
2024-12
3
3.35
2025-01
2
2.56
2025-02
0
3.52
2025-03
2
2.34
2025-04
2
1.85
2025-05
1
2.19
2025-06
4
2.48
2025-07
2
2.47
2025-08
1
1.85
2025-09
1
2
2025-10
3
2.75
2025-11
3
3.08
2025-12
4
2.91
2026-01
0
2.01
2026-02
3
2.5
2026-03
22
4.3
2026-04
12
4.4
2026-05
32
4.84
2026-06
124
15.24
This device (reports/month)Average device in HBE (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
1625507-2026-03890
Malfunction
Available
exact di
2026-06-30
1625507-2026-03893
Malfunction
—
exact di
2026-06-29
1625507-2026-03795
Malfunction
—
exact di
2026-06-26
1625507-2026-03748
Malfunction
—
exact di
2026-06-26
1625507-2026-03677
Malfunction
—
exact di
2026-06-26
1625507-2026-03719
Malfunction
Available
exact di
2026-06-26
1625507-2026-03747
Malfunction
—
exact di
2026-06-26
1625507-2026-03675
Malfunction
—
exact di
2026-06-26
1625507-2026-03722
Malfunction
—
exact di
2026-06-26
1625507-2026-03753
Malfunction
—
exact di
2026-06-26
1625507-2026-03725
Malfunction
—
exact di
2026-06-26
1625507-2026-03754
Malfunction
—
exact di
2026-06-26
1625507-2026-03715
Malfunction
—
exact di
2026-06-25
1625507-2026-03601
Malfunction
—
exact di
2026-06-25
1625507-2026-03659
Malfunction
—
exact di
Showing the most recent 200 of 235 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.