BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMITH

    MDR report key: 118466 · Received September 10, 1997

    Report

    Report Number
    3022808-1997-00002
    Event Type
    Injury
    Date Received
    September 10, 1997
    Report Date
    September 10, 1997
    Manufacturer
    BONDET
    Product Code
    HQY
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON SEPTEMBER 10, 1997 THE DIST REC'D A LETTER FROM THE COMPLAINANT THE DIST OF THE INJURY. THE COMPLAINANT WAS WEARING SLIDER SL2 SUNGLASSES WHILE RIDING HER BICYCLE. SHE FELL AND HIT THE GROUND BREAKING THE FRAME OF THE GLASSES. SHE REC'D A CUT AND REQUIRED PLASTIC SURGERY. THE DIST BELIEVES THE INJURY WAS CAUSED BY THE PERSON FALLING ON HER FACE AND NOT BY THE DIST'S PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMITH SUNGLASSES HQY BONDET * *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention