BEUDAMED
    FDA Adverse Event Injury Summary report: N

    10 MM TROCAR

    MDR report key: 20241 · Received March 14, 1995

    Report

    Report Number
    MW1005423
    Event Type
    Injury
    Date Received
    March 14, 1995
    Date of Event
    February 23, 1995
    Report Date
    February 28, 1995
    Manufacturer
    HALKEY-ROBERTS CORP.
    Product Code
    KDC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE THE SURGEON WAS INFLATING THE PREPERITONEAL DISTENTION BALLOON, THE BALLOON BURST INTO PIECES. PART OF THE BALLOON CAME OUT WITH THE SET, AND ONE PIECE OF BALLOON WAS RETRIEVED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 10 MM TROCAR 10 MM DISPOSABLE TROCAR KDC HALKEY-ROBERTS CORP. 1230013095

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention