BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIBERTY SPORT - LIBERTY SS2000 CHILDRENS EYEGLASSES TEMPLE PIN

    MDR report key: 4730572 · Received April 20, 2015

    Report

    Report Number
    MW5042316
    Event Type
    Other
    Date Received
    April 20, 2015
    Date of Event
    March 9, 2015
    Report Date
    April 9, 2015
    Product Code
    HQZ
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    MY SON IS (B)(6) YEARS OLD AND HAS A CONDITION CALLED CEREBRAL PALSY. BECAUSE OF HIS CEREBRAL PALSY, HE FALLS EASILY. HE ALSO REQUIRES GLASSES. I WOULD LIKE TO REPORT LIBERTY SPORT GLASSES WITH AN PROTRUDING TEMPLE PIN AS A SAFETY HAZARD. MY SON HAS FALLEN TWO TIMES IN THE PAST MONTH. ON BOTH OCCASIONS, HE HAS FALLEN ONTO HIS RIGHT SIDE, WHILE WEARING HIS GLASSES AND THE TEMPLE PIN HAS PENETRATED HIS TEMPLE. ALSO ON BOTH OCCASIONS, HE HAS REQUIRED STITCHES. THE FIRST INCIDENCE OCCURRED ON (B)(6) AND THE SECOND ON (B)(6). THE LACERATIONS WERE IN THE SAME GENERAL AREA BUT NOT THE EXACT SPOT. THE FIRST TIME IT OCCURRED, I THOUGHT THAT IT WAS JUST A FREAK ACCIDENT. BUT AFTER OCCURRING AGAIN, I THOUGHT THAT SOMETHING MUST BE DONE TO MAKE THE GLASSES SAFER. IT WAS A VERY TRAUMATIC EVENT AND I AM CONCERNED FOR THE SAFETY OF OTHER CHILDREN. THE COMPANY THAT MANUFACTURES THE EYEGLASSES IS LIBERTY SPORT. OUR PARTICULAR STYLE WAS CALLED THE LIBERTY SS2000 AND THE HAZARD IN THE TEMPLE PIN. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261385 LIBERTY SPORT - LIBERTY SS2000 CHILDRENS EYEGLASSES TEMPLE PIN NONE HQZ

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR