BEUDAMED
    FDA Adverse Event Other Summary report: N

    IVALON

    MDR report key: 65940 · Received January 29, 1997

    Report

    Report Number
    65940
    Event Type
    Other
    Date Received
    January 29, 1997
    Date of Event
    January 14, 1997
    Report Date
    January 28, 1997
    Manufacturer
    UNK
    Product Code
    EFQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    67 YEAR OLD FEMALE PRESENTED FOR REMOVAL OF BILATERAL BREAST IMPLANTS. THIS WAS PERFORMED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IVALON Implant POLYVINYL ALCOHOL EFQ UNK UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other