MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-04 for BOOST ADVANCED LED LIGHT THERAPY FACE MASK manufactured by The Light Salon Boost Limited.
[182515502]
On 5th use of boost face mask (manufactured by the light salon) suffered transient vision loss / blurred vision of 2 mins in duration with flash burns to eyes. Mask did not come with eye goggles; i had placed a blanket over my eyes (to cover them during mask use) for the cycle. Subsequent f/u with ophthalmologist confirmed flash burns to eyes. Placed on antibiotics. To date, no permanent vision loss appears to have occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093530 |
| MDR Report Key | 9793147 |
| Date Received | 2020-03-04 |
| Date of Report | 2020-03-02 |
| Date of Event | 2020-01-08 |
| Date Added to Maude | 2020-03-05 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BOOST ADVANCED LED LIGHT THERAPY FACE MASK |
| Generic Name | LIGHT BASED OVER THE COUNTER WRINKLE |
| Product Code | OHS |
| Date Received | 2020-03-04 |
| Lot Number | 10 1019KY |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THE LIGHT SALON BOOST LIMITED |
| Product Code | --- |
| Date Received | 2020-03-04 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-04 |