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.
17 linked reportsMalfunction 17
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
4.22
2019-02
0
3.4
2019-03
0
6.74
2019-04
0
12.55
2019-05
0
4.52
2019-06
0
3.32
2019-07
0
6.18
2019-08
0
3.12
2019-09
0
2.83
2019-10
0
3.28
2019-11
0
4.31
2019-12
0
3.51
2020-01
0
3.11
2020-02
0
5.89
2020-03
0
3.17
2020-04
0
3.28
2020-05
0
4.46
2020-06
0
4.41
2020-07
0
8
2020-08
0
6.3
2020-09
0
6.01
2020-10
0
7.85
2020-11
0
7.53
2020-12
0
9.37
2021-01
0
9.55
2021-02
0
8.4
2021-03
0
11.66
2021-04
0
10.73
2021-05
0
9.88
2021-06
0
8.34
2021-07
0
9.44
2021-08
0
10.03
2021-09
0
13.09
2021-10
0
9.27
2021-11
0
9.97
2021-12
0
12.63
2022-01
0
9.92
2022-02
0
11.58
2022-03
0
14.3
2022-04
0
14.51
2022-05
0
14.39
2022-06
0
14.42
2022-07
0
11.5
2022-08
0
11.07
2022-09
0
10.42
2022-10
0
11.08
2022-11
0
9.81
2022-12
0
10.71
2023-01
0
10.43
2023-02
0
10.7
2023-03
0
13.35
2023-04
0
12.15
2023-05
0
11.6
2023-06
0
9.7
2023-07
0
10.16
2023-08
0
12.61
2023-09
0
11.88
2023-10
0
12.64
2023-11
0
12.46
2023-12
0
11.87
2024-01
0
13.26
2024-02
0
15.03
2024-03
0
16.47
2024-04
0
14.21
2024-05
0
13.56
2024-06
0
16.4
2024-07
0
16.34
2024-08
0
13.88
2024-09
0
14.94
2024-10
0
18.58
2024-11
0
10.88
2024-12
0
9.27
2025-01
0
9.55
2025-02
0
7.3
2025-03
0
8.7
2025-04
0
9.17
2025-05
0
8.56
2025-06
0
8.89
2025-07
0
9.32
2025-08
0
10.4
2025-09
0
7.4
2025-10
1
12.21
2025-11
2
16.83
2025-12
0
30.93
2026-01
3
26.21
2026-02
0
14.6
2026-03
3
14.74
2026-04
2
22.65
2026-05
3
23.9
2026-06
3
21.59
This device (reports/month)Average device in FET, NWB, OWN (reports/device/month)
Failure-mode summaryAI-generated
17 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
Date
Report #
Type
Narrative
Link basis
2026-06-10
3002808148-2026-20016
Malfunction
Available
exact di
2026-06-06
3002808148-2026-19608
Malfunction
Available
exact di
2026-06-02
3002808148-2026-19114
Malfunction
Available
exact di
2026-05-29
3002808148-2026-18515
Malfunction
Available
exact di
2026-05-19
3002808148-2026-16665
Malfunction
Available
exact di
2026-05-06
3002808148-2026-14612
Malfunction
Available
exact di
2026-04-25
3002808148-2026-13303
Malfunction
Available
exact di
2026-04-09
3002808148-2026-10504
Malfunction
Available
exact di
2026-03-31
3002808148-2026-08841
Malfunction
Available
exact di
2026-03-30
3002808148-2026-08437
Malfunction
Available
exact di
2026-03-10
3002808148-2026-06537
Malfunction
Available
exact di
2026-01-07
3002808148-2026-00528
Malfunction
Available
exact di
2026-01-06
3002808148-2026-00368
Malfunction
Available
exact di
2026-01-05
3002808148-2026-00215
Malfunction
Available
exact di
2025-11-26
3002808148-2025-23470
Malfunction
Available
exact di
Showing 1–15 of 17
Regulatory clearances
510(k)K251336Substantially equivalent (SESE) · 2025-11-12clearance family
510(k)K242067Substantially equivalent (SESE) · 2025-04-02clearance 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.