BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRA TISSUE EXPANDER

    MDR report key: 1061347 · Received June 17, 2008

    Report

    Report Number
    MW5007317
    Event Type
    Injury
    Date Received
    June 17, 2008
    Date of Event
    June 5, 2008
    Report Date
    June 9, 2008
    Manufacturer
    PMT CORP.
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT BROUGHT TO OR FOR FAILED PMT EXPANDERS ORIGINALLY IMPLANTED IN '08. LEFT IMPLANT LEAKED AND RIGHT IMPLANT ROTATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRA TISSUE EXPANDER BREAST EXPANDER FWM PMT CORP. 5790971

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention