BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURE 2 WAY PEDIATRIC FOLEY

    MDR report key: 28182 · Received November 14, 1995

    Report

    Report Number
    28182
    Event Type
    Malfunction
    Date Received
    November 14, 1995
    Date of Event
    November 8, 1995
    Report Date
    November 9, 1995
    Manufacturer
    BOSTON PACIFIC MEDICAL, INC.
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AT LEAST TWO PEDIATRIC UROLOGICAL CATHETERS WERE NOTED TO BE DRY, ROTTED AND CRACKED. PACKAGING WAS INTACT AND EXPIRATION DATE LISTED AS 1997. CATHETERS WERE REMOVED FROM STOCK, NOT USED ON PTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURE 2 WAY PEDIATRIC FOLEY 2 WAY PEDIATRIC FOLEY KOD BOSTON PACIFIC MEDICAL, INC. 31001; 30601

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other