BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 491541 · Received October 17, 2003

    Report

    Report Number
    491541
    Event Type
    Malfunction
    Date Received
    October 17, 2003
    Date of Event
    June 1, 2003
    Report Date
    July 1, 2003
    Manufacturer
    PMT CORPORATION TISSUE EXPANDER
    Product Code
    LCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FAILED TISSUE EXPANDER. INTERVENTION WAS REQUIRED TO PREVENT SERIOUS INJYRY. THIS EVENT CAUSED ADD'L SURGERY. REQUIRING A RETURN TO O.R. TO REPLACE THE TISSUE EXPANDER BY THE DOCTOR. DEVICE USAGE PROBLEM: DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * TISSUE EXPANDER LCJ PMT CORPORATION TISSUE EXPANDER * 052903

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR