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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DR. DENNIS GROSS SKINCARE LLC DRX SPECTRALITE EYECARE PRO MASQUE LRD; LIGHT BASED WRINKLE REDUCTION
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DR. DENNIS GROSS SKINCARE LLC DRX SPECTRALITE EYECARE PRO MASQUE LRD; LIGHT BASED WRINKLE REDUCTION Back to Search Results
Model Number 6 9586656711 0
Medical Device Problem Code Insufficient Information (3190)
Health Effect - Clinical Codes Pain (1994); Burning Sensation (2146); Ulcer (2274)
Date of Event 04/22/2018
Type of Reportable Event Serious Injury
Event or Problem 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.
 
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Brand Name
DRX SPECTRALITE EYECARE PRO MASQUE LRD
Common Device Name
LIGHT BASED WRINKLE REDUCTION
Manufacturer (Section D)
DR. DENNIS GROSS SKINCARE LLC
444 madison ave
ste 500
new york NY 10022
MDR Report Key7534222
Report NumberMW5077384
Device Sequence Number17672650
Product Code OHS
Combination Product (Y/N)N
Initial Reporter StateCO
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Voluntary
Initial Reporter Occupation Patient
Type of Report Initial
Report Date (Section B) 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
Operator of Device Lay User/Patient
Device Model Number6 9586656711 0
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date05/21/2018
Patient Sequence Number1
Outcome Attributed to Adverse Event Disability;
Patient Age63 YR
Patient Weight48
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