BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANDELA V BEAM LASER

    MDR report key: 1081430 · Received July 24, 2008

    Report

    Report Number
    MW5007803
    Event Type
    Injury
    Date Received
    July 24, 2008
    Date of Event
    April 10, 2008
    Report Date
    July 24, 2008
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HAD CANDELA VBEAM PREFORMED BY A DR. AFTER PROCEDURE, I SUFFERED IMMENSE SWELLING ON RIGHT SIDE OF FACE. IT HAS BEEN 3 MONTHS AND I STILL HAVE SERIOUS RESIDUAL SWELLING WITH EDEMA. I WENT TO DR FOR SKIN REGUVENATION. SHE SAID VBEAM WOULD BE HER CHOICE. I HAVE SINCE GONE BACK TO HER, AND SHE GAVE ME ANTIHISTAMINES AND TOLD ME THIS SHOULD RESOLVE. I HAVE GONE TO ANOTHER DR AND WHAT I HAVE IS SCARRING DERMAL AND EDEMA. I AM VERY WORRIED THIS IS PERMANENT AS I AM SEEKING ANOTHER OPINION. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: SKIN REGUVENATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CANDELA V BEAM LASER CANDELA PERFECTA GEX 595 PERFECTA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention CANDELA PERFECTA V BEAM LASER