BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXI-CUFF RETENTION TIP

    MDR report key: 278159 · Received May 16, 2000

    Report

    Report Number
    278159
    Event Type
    Injury
    Date Received
    May 16, 2000
    Date of Event
    February 24, 2000
    Report Date
    April 14, 2000
    Manufacturer
    E-Z-EM CARIBE
    Product Code
    FGD
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, AT COMPLETION OF THE STUDY, THE PT COMPLAINED OF ABDOMINAL PAIN AND EXTRAVASATION OF BARIUM WAS NOTED AROUND THE RECTUM. THE PT WAS SENT TO THE EMERGENCY ROOM AND WAS DIAGNOSED WITH A PERFORATED RECTUM. PT WAS SENT TO THE OPERATING ROOM AND UNDERWENT A TRANSVERSE LOOP COLOSTOMY AND PRESACRAL DRAINAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXI-CUFF RETENTION TIP ENEMA TIP WITH NON-LATEX CUFF FGD E-Z-EM CARIBE NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention E-Z-EM ENEMA BAG WITH TUBING - CAT NO UNK.