BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VBEAM

    MDR report key: 3201688 · Received June 28, 2013

    Report

    Report Number
    1218402-2013-00014
    Event Type
    Injury
    Date Received
    June 28, 2013
    Date of Event
    May 3, 2013
    Report Date
    June 28, 2013
    Manufacturer
    CANDELA CORPORATION
    Product Code
    GEX
    PMA / PMN Number
    K051359
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS INSTALLED AT THE USER SITE (B)(4) 2008. THERE HAVE BEEN NO CLINICAL COMPLAINTS FROM THE USER SITE REGARDING THIS SPECIFIC SERIAL NUMBER SINCE THAT TIME. THE PRODUCT DEVICE HISTORY RECORD AND SERVICE HISTORY WAS REVIEWED 06/28/2013 WITH NO ISSUES FOUND. THE TREATMENT PARAMETERS REPORTEDLY USED BY THE OPERATOR WERE WITHIN THE TREATMENT GUIDELINES, EXCEPT FOR THE FLUENCE AND PULSE DURATION, WHICH WERE HIGHER THAN WHAT WAS RECOMMENDED. BASED ON WHAT WAS REPORTED BY THE SITE, THE HIGHER FLUENCE SETTING THAT WAS USED MAY HAVE BEEN A CONTRIBUTING FACTOR TO THE INJURY. A CANDELA FIELD SERVICE ENGINEER INSPECTED THE UNIT AND REPORTED THAT THE UNIT WAS OPERATING WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    A SITE REPORTED THAT A FEMALE PT REC'D A LASER TREATMENT FOR INFLAMMATORY ACNE VULGARIS ON THE CHIN AND REPORTED THAT THE PT RESPONDED WITH BLISTERING AND SCARRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296955 VBEAM DERMATOLOGY LASER GEX CANDELA CORPORATION 9914-00-0300 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability