iLED · recalls, adverse events, clearances

Adverse-event reports (MAUDE)

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 14Injury 2

Monthly adverse-event reports for this device versus the product-code average.
Month	This device (reports)	Product-code average (reports per device)
2019-02	0	1
2019-03	0	1
2019-04	0	1
2019-05	0	2
2019-07	0	2
2019-08	0	2
2019-09	0	3
2019-11	0	1
2019-12	0	2.5
2020-01	0	3
2020-02	0	3
2020-03	0	1.33
2020-04	0	2
2020-05	0	1
2020-06	0	2
2020-07	0	1.4
2020-08	0	2.67
2020-09	0	1
2020-10	0	1.75
2020-11	0	2
2020-12	0	1
2021-01	0	1
2021-02	0	1.83
2021-03	0	1.88
2021-04	0	1.43
2021-05	0	1.8
2021-06	0	2
2021-08	0	1.25
2021-09	0	1
2021-10	0	2.78
2021-11	0	1
2021-12	0	1.1
2022-01	0	1.22
2022-02	0	1.25
2022-03	0	4.57
2022-04	0	1
2022-05	0	2.67
2022-06	0	1.25
2022-07	0	2.6
2022-08	0	2.33
2022-09	2	1.47
2022-10	1	1.58
2022-11	0	1.4
2022-12	0	1.08
2023-01	0	1.27
2023-02	0	3.17
2023-03	0	2.58
2023-04	0	1.17
2023-05	0	1.22
2023-06	0	2.08
2023-07	0	1.6
2023-08	0	1.88
2023-09	0	6
2023-10	0	1.78
2023-11	0	1.8
2023-12	2	1.64
2024-01	0	1.79
2024-02	0	1.67
2024-03	0	1.64
2024-04	5	3
2024-05	0	1.89
2024-06	0	1.91
2024-07	0	2.73
2024-08	0	2.33
2024-09	2	2.15
2024-10	0	1.74
2024-11	0	1.41
2024-12	0	1.85
2025-01	0	3.39
2025-02	2	1.87
2025-03	1	1.65
2025-04	0	2.17
2025-05	0	1.78
2025-06	0	2.17
2025-07	0	1.88
2025-08	0	1.35
2025-09	0	2.5
2025-10	0	2.14
2025-11	0	1.93
2025-12	0	2.14
2026-01	0	2.6
2026-02	0	1.3
2026-03	1	3.45
2026-04	0	3
2026-05	0	2
2026-06	0	3.08

This device (reports/month)Average device in FQP, FSQ, FSY, FTD (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
2026-03-30	3007143268-2026-00021	Malfunction	Available	exact di
2025-03-13	MW5167645	Injury	Available	model number
2025-02-28	3007143268-2025-00016	Malfunction	Available	exact di
2024-09-24	3007143268-2024-00048	Injury	Available	model number
2024-09-24	3007143268-2024-00049	Malfunction	Available	model number
2024-04-08	3007143268-2024-00014	Malfunction	Available	model number
2024-04-05	3007143268-2024-00012	Malfunction	Available	exact di
2024-04-05	3007143268-2024-00013	Malfunction	Available	exact di
2023-12-20	3007143268-2023-00047	Malfunction	Available	exact di
2022-10-13	9681407-2022-00021	Malfunction	Available	exact di
2022-09-30	9681407-2022-00023	Malfunction	Available	exact di
2022-09-29	9681407-2022-00022	Malfunction	Available	exact di

Showing the most recent 12 of 16 linked reports.

Regulatory clearances

None linked.

Manufacturer compliance record

None in the loaded window.

Similar devices