BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDPOR EXTERNAL EAR IMPLANT

    MDR report key: 97350 · Received June 11, 1997

    Report

    Report Number
    MW1011456
    Event Type
    Malfunction
    Date Received
    June 11, 1997
    Date of Event
    April 30, 1997
    Report Date
    May 15, 1997
    Manufacturer
    POREX SURGICAL, INC.
    Product Code
    FZD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT IS STATUS POST 70% 3RD DEGREE BURN ON 6/5/89. AS A RESULT OF THE BURN, PT LOST RIGHT EAR. STAGED RECONSTRUCTION OF RIGHT EXTERNAL EAR BEGUN WITH IMPLANT OF MED-POR EXTERNAL EAR SURGICAL IMPLANT ON 2/7/97. PT DID WELL UNTIL 4/29/97 WHEN EXPOSURE OF TIPS OF THE GRAFT WAS REPORTED WITHOUT SIGNS OF INFECTION OR CELLULITIS. THE IMPLANT WAS REMOVED AT SURGERY ON 4/30/97.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDPOR EXTERNAL EAR IMPLANT Implant EXTERNAL EAR IMPLANT FZD POREX SURGICAL, INC. * 182040396

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Other