BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALEX TRIVANTAGE

    MDR report key: 2875257 · Received December 13, 2012

    Report

    Report Number
    1218402-2012-00012
    Event Type
    Injury
    Date Received
    December 13, 2012
    Date of Event
    November 13, 2012
    Report Date
    December 13, 2012
    Manufacturer
    CANDELA CORP.
    Product Code
    GEX
    PMA / PMN Number
    K081324
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS INSTALLED AT THE USER SITE (B)(4) 2012. THERE HAVE BEEN NO CLINICAL COMPLAINTS REGARDING THIS SPECIFIC SERIAL NUMBER SINCE THAT TIME. THE PRODUCT DEVICE HISTORY RECORD AND SERVICE HISTORY WERE REVIEWED (B)(4) 2012 WITH NO ISSUES FOUND. THE TREATMENT PARAMETERS REPORTEDLY USED BY THE OPERATOR WERE WITHIN THE PARAMETERS AS RECOMMENDED BY CANDELA'S TREATMENT GUIDELINES. UPON REVIEW BY THE CANDELA CLINICAL MANAGER, IT WAS SUGGESTED THAT THE BLISTERS WERE LIKELY DUE TO AN ALLERGIC RESPONSE TO THE TREATMENT. A CANDELA FIELD SERVICE ENGINEER INSPECTED THE UNIT INVOLVED IN THE EVENT AND REPORTED THAT THE UNIT WAS OPERATING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A SITE IN (B)(6) REPORTED THAT A PATIENT RECEIVED TREATMENT FOR TATTOO REMOVAL AND RESPONDED WITH BLISTERS ON THE TREATED AREA. THE BLISTERS WERE REPORTED 24 HOURS POST TREATMENT AND WERE REPORTED TO APPEAR ON THE TREATED AREAS OF THE TATTOO THAT HAD BLUE INK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALEX TRIVANTAGE DERMATOLOGY LASER GEX CANDELA CORP. 9914-00-2025 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability