BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VBEAM

    MDR report key: 2469273 · Received January 27, 2012

    Report

    Report Number
    1218402-2012-00001
    Event Type
    Injury
    Date Received
    January 27, 2012
    Date of Event
    April 29, 2010
    Report Date
    January 27, 2012
    Manufacturer
    CANDELA CORP.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT INFORMATION REGARDING THE LOCATION WHERE THE PATIENT RECEIVED TREATMENT OR INFORMATION REGARDING THE DEVICE, CANDELA CANNOT PERFORM AN EVALUATION OF THE DEVICE. THE COMPLAINT DATABASE HAS BEEN REVIEWED AND A SPECIFIC COMPLAINT ASSOCIATED WITH THIS PARTICULAR EVENT OR A SIMILAR EVENT DESCRIBING THE TYPE OF INJURY REPORTED BY THE PATIENT HAS NOT BEEN IDENTIFIED.

    Description of Event or Problem · 1

    A PATIENT SUBMITTED A VOLUNTARY REPORT TO THE FDA MEDWATCH PROGRAM (REPORT NO. (B)(4)). THE PATIENT REPORTED THAT THE REGISTERED NURSE USED IMPROPER SETTINGS TO TREAT THEIR TELANGIECTASIA. THE PATIENT ALSO REPORTED BLACKENING OF THE SKIN AND BLISTERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VBEAM DERMATOLOGY LASER GEX CANDELA CORP. UNKNOWN NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention