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.
18 linked reportsMalfunction 12Injury 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
3.02
2019-02
0
3.8
2019-03
0
3.07
2019-04
0
1.84
2019-05
0
2.02
2019-06
0
1.56
2019-07
0
1.72
2019-08
0
4.08
2019-09
0
2.75
2019-10
0
4.2
2019-11
0
4.43
2019-12
0
4.68
2020-01
0
3.33
2020-02
0
2.1
2020-03
0
3.9
2020-04
0
2.54
2020-05
0
1.48
2020-06
0
1.69
2020-07
0
2.68
2020-08
0
2.92
2020-09
0
2.89
2020-10
0
4.06
2020-11
0
2.7
2020-12
0
2.89
2021-01
0
1.16
2021-02
0
2.22
2021-03
0
1.84
2021-04
0
1.97
2021-05
0
1.68
2021-06
0
2.28
2021-07
0
3.03
2021-08
0
2.28
2021-09
0
4
2021-10
0
2.79
2021-11
0
2
2021-12
0
1.59
2022-01
0
2.18
2022-02
0
1.95
2022-03
0
1.48
2022-04
0
2.5
2022-05
2
2.7
2022-06
0
2.17
2022-07
0
1.83
2022-08
0
2.12
2022-09
0
2.06
2022-10
0
2.52
2022-11
4
2.26
2022-12
0
2.09
2023-01
0
2.68
2023-02
0
2.11
2023-03
2
2.35
2023-04
0
1.65
2023-05
0
2.34
2023-06
0
2.05
2023-07
0
1.75
2023-08
0
2.82
2023-09
0
3.4
2023-10
0
6.86
2023-11
0
5.92
2023-12
0
7.38
2024-01
2
5
2024-02
0
6.15
2024-03
0
6.35
2024-04
0
8.9
2024-05
0
8.71
2024-06
0
6.63
2024-07
0
10.21
2024-08
0
12.34
2024-09
0
17.49
2024-10
0
13.78
2024-11
0
12.6
2024-12
0
9.08
2025-01
0
8.76
2025-02
0
14.62
2025-03
0
13.68
2025-04
0
10.64
2025-05
0
8.37
2025-06
0
9.62
2025-07
0
16.06
2025-08
0
9.05
2025-09
0
10.32
2025-10
0
15.2
2025-11
0
13.17
2025-12
2
11.91
2026-01
4
9.37
2026-02
2
9.14
2026-03
0
11.44
2026-04
0
11.39
2026-05
0
12.38
2026-06
0
13.23
This device (reports/month)Average device in ETN, GWF, IKN, PDQ (reports/device/month)
Failure-mode summaryAI-generated
18 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
Date
Report #
Type
Narrative
Link basis
2026-02-20
2027467-2026-00026
Malfunction
Available
exact di
2026-01-13
2027467-2026-00010
Malfunction
Available
exact di
2026-01-06
2027467-2026-00001
Injury
Available
exact di
2025-12-15
2027467-2025-00258
Injury
Available
exact di
2024-01-13
2027467-2023-00095
Malfunction
Available
exact di
2023-03-18
2027467-2023-00017
Malfunction
Available
exact di
2022-11-23
2027467-2022-00084
Malfunction
Available
exact di
2022-11-16
2027467-2022-00087
Malfunction
Available
exact di
2022-05-21
2027467-2022-00031
Injury
Available
exact di
Showing the most recent 9 of 18 linked reports.
Regulatory clearances
510(k)K182542Substantially equivalent (SESE) · 2019-02-22clearance 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.