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.
462 linked reportsMalfunction 448Injury 14
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
24
4.57
2019-02
3
2.6
2019-03
0
3.45
2019-04
1
3.33
2019-05
3
3.15
2019-06
1
3.11
2019-07
6
3.62
2019-08
3
3.74
2019-09
8
3.92
2019-10
5
3.72
2019-11
6
4.59
2019-12
5
4.75
2020-01
5
4.79
2020-02
1
3.72
2020-03
2
4.43
2020-04
6
5.91
2020-05
1
4.24
2020-06
9
4.29
2020-07
4
4.32
2020-08
0
4.54
2020-09
0
3.97
2020-10
1
4.51
2020-11
23
5.97
2020-12
2
5.53
2021-01
6
5.32
2021-02
6
4.7
2021-03
1
4.81
2021-04
2
5.04
2021-05
2
4.72
2021-06
2
4.26
2021-07
2
4.85
2021-08
1
4.52
2021-09
3
4.68
2021-10
3
4.98
2021-11
2
5.09
2021-12
1
5.04
2022-01
6
4.67
2022-02
2
4.37
2022-03
1
4.86
2022-04
0
4.45
2022-05
1
4.93
2022-06
2
4.22
2022-07
1
4.36
2022-08
19
5.82
2022-09
3
4.68
2022-10
14
5.29
2022-11
2
4.83
2022-12
6
5.4
2023-01
3
5.58
2023-02
1
5.46
2023-03
3
6.1
2023-04
2
6.58
2023-05
2
6.67
2023-06
8
7.12
2023-07
4
6.4
2023-08
9
6.63
2023-09
2
5.65
2023-10
5
6.61
2023-11
5
4.84
2023-12
15
6.41
2024-01
7
5.68
2024-02
7
6.45
2024-03
4
8.97
2024-04
5
13.7
2024-05
16
13.88
2024-06
7
14.96
2024-07
6
13.82
2024-08
4
8.5
2024-09
1
8.31
2024-10
3
6.11
2024-11
11
6.2
2024-12
6
5.48
2025-01
8
5.69
2025-02
1
4.69
2025-03
5
5.06
2025-04
6
5.32
2025-05
3
5.79
2025-06
8
5.63
2025-07
11
5
2025-08
12
5.41
2025-09
1
4.37
2025-10
4
4.79
2025-11
6
6.43
2025-12
6
5.95
2026-01
14
5.86
2026-02
6
6.39
2026-03
4
5.9
2026-04
3
6.05
2026-05
13
6.75
2026-06
8
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
2026-06-23
1221934-2026-02738
Malfunction
—
exact di
2026-06-23
1221934-2026-02746
Malfunction
Available
exact di
2026-06-23
1221934-2026-02740
Malfunction
—
exact di
2026-06-23
1221934-2026-02736
Malfunction
—
exact di
2026-06-12
1221934-2026-02511
Malfunction
Available
exact di
2026-06-10
1221934-2026-02484
Malfunction
Available
exact di
2026-06-10
1221934-2026-02481
Malfunction
Available
exact di
2026-06-09
1221934-2026-02469
Malfunction
Available
exact di
2026-05-29
1221934-2026-02323
Malfunction
Available
exact di
2026-05-29
1221934-2026-02324
Malfunction
Available
exact di
2026-05-28
1221934-2026-02258
Malfunction
Available
exact di
2026-05-27
1221934-2026-02219
Malfunction
Available
exact di
2026-05-27
1221934-2026-02205
Malfunction
Available
exact di
2026-05-27
1221934-2026-02212
Malfunction
Available
exact di
2026-05-27
1221934-2026-02240
Malfunction
Available
exact di
Showing the most recent 200 of 462 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.