MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-21 for DRX SPECTRALITE EYECARE PRO MASQUE LRD 6 9586656711 0 manufactured by Dr. Dennis Gross Skincare Llc.
[109040889]
Dr. Dennis gross drx spectralite eyecare pro masque led is "fda cleared. " it is essentially a pair of goggles that delivers a full spectrum of light to decrease fine line and wrinkle around the eyes and the mid forehead area. It is harmful. The instructions are to use the product daily for 10 wks. I purchased the device on (b)(6) 2018 and used it for 4 wks. I developed a dark red patch on my forehead on (b)(6). The red patch was actually covering an ulcer, similar to a decubitus ulcer. It opened up and required a dr visit. The pain was a searing, burning pain. As of this writing on (b)(6), it still has not healed and is likely to cause scarring or future treatment. Dates of use: (b)(6) 2018 - (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5077384 |
| MDR Report Key | 7534222 |
| Date Received | 2018-05-21 |
| Date of Report | 2018-05-07 |
| Date of Event | 2018-04-22 |
| Date Added to Maude | 2018-05-22 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DRX SPECTRALITE EYECARE PRO MASQUE LRD |
| Generic Name | LIGHT BASED WRINKLE REDUCTION |
| Product Code | OHS |
| Date Received | 2018-05-21 |
| Model Number | 6 9586656711 0 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DR. DENNIS GROSS SKINCARE LLC |
| Manufacturer Address | 444 MADISON AVE STE 500 NEW YORK NY 10022 US 10022 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2018-05-21 |