BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK

    MDR report key: 1920574 · Received December 7, 2010

    Report

    Report Number
    1920574
    Event Type
    Malfunction
    Date Received
    December 7, 2010
    Date of Event
    November 29, 2010
    Report Date
    December 3, 2010
    Manufacturer
    UNK
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT HAD BILATERAL REMOVAL OF BREAST IMPLANTS WITH LEFT ONE FOUND TO HAVE 2 DEFECTS 1 CM AND 1.7 CM WITH OOZING OF VISCOUS CONTENTS. PT DID NOT HAVE IMPLANTS PLACED WITHIN OUR HOSPITAL SYSTEM. UNK AGE OF IMPLANTS. PER PATHOLOGY THERE WERE NO IDENTIFIERS TO THE IMPLANTS UPON GROSS ASSESSMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK BREAST IMPLANTS FWM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other