BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 3763553 · Received April 8, 2014

    Report

    Report Number
    1218402-2014-00009
    Event Type
    Injury
    Date Received
    April 8, 2014
    Date of Event
    February 18, 2009
    Report Date
    April 18, 2014
    Manufacturer
    CANDELA CORP.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS CURRENTLY ONGOING. AWAITING FURTHER DETAILS FROM LITIGATION.

    Description of Event or Problem · 1

    CANDELA'S IN-HOUSE LEGAL COUNSEL RECEIVED A LEGAL NOTICE THAT A PATIENT RECEIVED LASER HAIR REMOVAL AND REPORTED BURNS AND SUBSEQUENT NERVE DAMAGE ON THE TREATED AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211432 UNK DERMATOLOGY LASER GEX CANDELA CORP. UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability