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.
16 linked reportsMalfunction 10Injury 6
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
2.75
2019-02
0
3.54
2019-03
0
3.02
2019-04
0
1.99
2019-05
0
2.07
2019-06
0
1.54
2019-07
0
1.75
2019-08
0
4.02
2019-09
0
2.74
2019-10
0
3.92
2019-11
0
4.29
2019-12
0
4.5
2020-01
0
3.36
2020-02
0
2.15
2020-03
0
3.77
2020-04
0
2.48
2020-05
0
1.62
2020-06
0
1.91
2020-07
0
2.66
2020-08
0
2.88
2020-09
0
2.85
2020-10
0
3.96
2020-11
0
2.66
2020-12
0
2.82
2021-01
0
1.19
2021-02
0
2.11
2021-03
0
2.12
2021-04
0
2.01
2021-05
0
1.92
2021-06
0
2.62
2021-07
0
3.23
2021-08
0
2.53
2021-09
0
3.79
2021-10
0
2.71
2021-11
0
2.05
2021-12
0
1.96
2022-01
0
2.11
2022-02
0
2.07
2022-03
0
1.69
2022-04
0
2.7
2022-05
0
2.68
2022-06
0
2.23
2022-07
0
1.94
2022-08
0
2.24
2022-09
0
2.07
2022-10
0
2.62
2022-11
0
2.31
2022-12
0
2.11
2023-01
0
2.58
2023-02
0
2.1
2023-03
0
2.34
2023-04
0
1.66
2023-05
0
2.34
2023-06
0
1.98
2023-07
0
1.78
2023-08
0
2.73
2023-09
0
3.36
2023-10
0
6.64
2023-11
0
5.88
2023-12
0
7
2024-01
0
4.84
2024-02
0
5.99
2024-03
0
5.88
2024-04
0
8.69
2024-05
0
8.53
2024-06
0
6.47
2024-07
0
9.86
2024-08
0
12.15
2024-09
0
16.82
2024-10
0
13.21
2024-11
0
11.9
2024-12
0
8.84
2025-01
0
8.51
2025-02
0
13.86
2025-03
0
13.01
2025-04
0
9.63
2025-05
0
8.19
2025-06
0
9.5
2025-07
4
15.5
2025-08
0
8.94
2025-09
0
9.91
2025-10
0
14.54
2025-11
0
12.31
2025-12
6
10.74
2026-01
2
8.81
2026-02
0
8.73
2026-03
2
10.29
2026-04
0
10.56
2026-05
2
11.46
2026-06
0
12.6
This device (reports/month)Average device in ETN, GWF, GXY, GXZ, IKN, PDQ (reports/device/month)
Failure-mode summaryAI-generated
16 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
Date
Report #
Type
Narrative
Link basis
2026-05-27
2027467-2026-00103
Malfunction
Available
exact di
2026-03-06
2027467-2026-00041
Malfunction
Available
exact di
2026-01-27
2027467-2026-00006
Injury
Available
exact di
2025-12-15
2027467-2025-00277
Malfunction
Available
exact di
2025-12-05
2027467-2025-00265
Malfunction
Available
exact di
2025-12-05
2027467-2025-00266
Malfunction
Available
exact di
2025-07-16
2027467-2025-00137
Injury
Available
exact di
2025-07-10
2027467-2025-00128
Injury
Available
exact di
Showing the most recent 8 of 16 linked reports.
Regulatory clearances
510(k)K252842Substantially equivalent (SESE) · 2026-01-11clearance family
510(k)K234092Substantially equivalent (SESE) · 2024-04-19clearance 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.