BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-BEAM PULSED LASER

    MDR report key: 4877654 · Received June 18, 2015

    Report

    Report Number
    4877654
    Event Type
    Malfunction
    Date Received
    June 18, 2015
    Date of Event
    June 9, 2015
    Report Date
    June 18, 2015
    Manufacturer
    CANDELA CORP
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS HERE FOR V-BEAM TREATMENT OF PORT WINE STAIN ON RIGHT SIDE OF FACE. WE WERE UNABLE TO GET THE SETTINGS NEEDED BY THE DR FOR THIS PATIENT. THE ONLY SETTING WE COULD GET WAS MUCH LOWER. THE INCIDENT REPORT HAS THE SETTINGS WE WERE UNABLE TO GET. PATIENT WAS SENT HOME WITHOUT TREATMENT.THIS WAS THE PATIENT SAFETY REPORT: PATIENT CAME FOR TREATMENT OF PORT WINE STAIN ON RIGHT FACE USING VBEAM TREATMENT. LASER HANDPIECE 3X10 CALIBRATED; WOULD NOT CALIBRATE AT 7MM HANDPIECE. SETTINGS 3 WIDTH AND 12 FLUENCE; NEEDED THESE SETTINGS. CASE CANCELED. UNABLE TO DO PRESCRIBED TREATMENT. PATIENT SENT HOME.======================MANUFACTURER RESPONSE FOR PULSED LASER, CANDELA V-BEAM LASER (PER SITE REPORTER).======================I LEFT A MESSAGE WITH THE RMA EXTENSION AT CANDELA CORP TO CALL ME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396021 V-BEAM PULSED LASER POWERED LASER SURGICAL INSTRUMENT GEX CANDELA CORP * *

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR NO, SHE WAS ONLY HERE FOR LASER OF A PORT WINE| NO OTHER THERAPIES| STAIN ON HER FACE.