BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GIANTURCO-HELFRICH-EBERBACK

    MDR report key: 207848 · Received January 25, 1999

    Report

    Report Number
    207848
    Event Type
    Malfunction
    Date Received
    January 25, 1999
    Date of Event
    December 8, 1998
    Report Date
    January 4, 1999
    Manufacturer
    COOK SURGICAL
    Product Code
    EXN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT EXPERIENCING LOWER ABDOMINAL DISCOMFORT AND WAS SEEN IN EMERGENCY ROOM ON 11/30/1998. A PIECE OF WIRE WAS REMOVED WHICH HAD BECOME DISCONNECTED FROM HERNIA DISK. AT THIS TIME AN X-RAY REVEALED 2 TO 3 MORE WIRES STILL ATTACHED TO DISK, TO AVOID FURTHER DISCOMFORT OR POSSIBLY AN INTERNAL BOWEL INJURY EXAMINING PHYSICIAN HAD PT SCHEDULED FOR REMOVAL OF ASSOCIATED WIRES. TWO MORE WIRES REMOVED ON 12/08/1998.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GIANTURCO-HELFRICH-EBERBACK Implant HERNIA REPAIR SET EXN COOK SURGICAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR