BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUREFLEX LASER FIBER

    MDR report key: 2171505 · Received June 30, 2011

    Report

    Report Number
    2937094-2011-01363
    Event Type
    Malfunction
    Date Received
    June 30, 2011
    Date of Event
    May 1, 2011
    Report Date
    June 6, 2011
    Manufacturer
    AMS INNOVATION CENTER - SILICON VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K050108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER ON (B)(6) 2011 THE FIBER BLEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUREFLEX LASER FIBER SUREFLEX FIBER GEX AMS INNOVATION CENTER - SILICON VALLEY NA R-200-1022B

    Patients

    Seq Age Sex Outcome Treatment
    1 Other