BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVAL PREPERITONEAL DISTENTION BALLOON

    MDR report key: 388533 · Received April 9, 2002

    Report

    Report Number
    MW1024724
    Event Type
    Injury
    Date Received
    April 9, 2002
    Report Date
    April 9, 2002
    Manufacturer
    US SURGICAL/TYCO HEALTHCARE GROUP
    Product Code
    GCJ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AFTER SURGEON INFLATED BALLOON AND THEN BEGAN REMOVING IT FROM THE PREPERITONEAL SPACE BALLOON CAME OFF THE DEVICE. CLAMP USED TO REMOVE BALLOON FROM ABDOMEN. NO INJURY TO PT. ITEM MAILED BY SURGERY TO CO IN 03/2002. ONCE AGAIN SURGERY INFORMED ON PROPER PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OVAL PREPERITONEAL DISTENTION BALLOON DISTENTION BALLOON AND INFLATION BULB GCJ US SURGICAL/TYCO HEALTHCARE GROUP PDB*S2 105203

    Patients

    Seq Age Sex Outcome Treatment
    1 *