BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CROW INSUL FCPS 9", 4000 JAW

    MDR report key: 382398 · Received March 15, 2002

    Report

    Report Number
    1038548-2002-00004
    Event Type
    Malfunction
    Date Received
    March 15, 2002
    Date of Event
    February 8, 2002
    Report Date
    March 14, 2002
    Manufacturer
    SNOWDEN PENCER, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING A BREAST AUGMINTATION, THE INSULATION BROKE OFF IN THE PATIENT WOUND. IT WAS RECOVERED. NO REPORT TO THE FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CROW INSUL FCPS 9", 4000 JAW * GEI SNOWDEN PENCER, INC. 32-0531 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other