BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPACEMAKER

    MDR report key: 78285 · Received March 19, 1997

    Report

    Report Number
    46643-1997-00001
    Event Type
    Other
    Date Received
    March 19, 1997
    Report Date
    March 19, 1997
    Manufacturer
    GENERAL SURGICAL INNOVATIONS
    Product Code
    GDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT DEVELOPED AN INFECTION AFTER BREAST AUGMENTATION SURGERY. NO FURTHER INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPACEMAKER BALLOON DISSECTOR GDI GENERAL SURGICAL INNOVATIONS 99-1914-01 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other