BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPACEMAKER I

    MDR report key: 171390 · Received June 5, 1998

    Report

    Report Number
    2951239-1998-00002
    Event Type
    Injury
    Date Received
    June 5, 1998
    Date of Event
    April 27, 1998
    Report Date
    June 5, 1998
    Manufacturer
    GENERAL SURGICAL INNOVATIONS
    Product Code
    GDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, THE PHYSICIAN ENCOUNTERED A PROBLEM WITH THE DISRUPTION OF THE EPIGASTRIC VESSEL DURING A RIGHT INGUINAL HERNIA REPAIR. REPORTEDLY, THE BALLOON EXPLODED AFTER INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPACEMAKER I SURGICAL BALLOON DISSECTOR GDI GENERAL SURGICAL INNOVATIONS 900 CC 706001

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention