MAUDE Adverse Event Report: DR. DENNIS GROSS SKINCARE LLC DRX SPECTRALITE EYECARE PRO MASQUE LRD; LIGHT BASED WRINKLE REDUCTION

Model Number 6 9586656711 0

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Burning Sensation (2146); Ulcer (2274)

Event Date 04/22/2018

Event Type  Injury  

Event Description

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.

• Brand Name: DRX SPECTRALITE EYECARE PRO MASQUE LRD
• Type of Device: LIGHT BASED WRINKLE REDUCTION
• Manufacturer (Section D): DR. DENNIS GROSS SKINCARE LLC ; 444 madison ave; ste 500; new york NY 10022
• MDR Report Key: 7534222
• MDR Text Key: 109040889
• Report Number: MW5077384
• Device Sequence Number: 1
• Product Code: OHS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 6 9586656711 0
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/21/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 63 YR
• Patient Weight: 48