BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IDEAS FOR MEDICINE-IMPLANTABLE DEVICES

    MDR report key: 38134 · Received September 11, 1996

    Report

    Report Number
    38134
    Event Type
    Injury
    Date Received
    September 11, 1996
    Date of Event
    July 18, 1996
    Report Date
    July 31, 1996
    Manufacturer
    IMPLANTABLE DEVICES
    Product Code
    GBZ
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON 7/12/96 THE CATHETER WAS INFLATED PRIOR TO CHOLELAPAROSCOPE SURGERY TO CHECK THE BALLOON WHICH APPEARED INTACT. EXTRAVASATION WAS NOTED DURING THE CHOLANGIOGRAM FROM THE BALLOON SITE. THE BALLOON HAD BEEN INFLATED WITH AIR, DEFLATED, AND REINFLATED WITH NORMAL SALINE, UP TO 1CC. THE PT RETURNED TO SURGERY ON 7/18/96 FOR REPAIR OF A COMMON BILE DUCT TEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IDEAS FOR MEDICINE-IMPLANTABLE DEVICES REDDICK CATHETER GBZ IMPLANTABLE DEVICES * *

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention