BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALLEGIANCE SILICONE ELASTOMER COATED FOLEY CATHETER

    MDR report key: 381236 · Received March 8, 2002

    Report

    Report Number
    9611710-2002-00001
    Event Type
    Other
    Date Received
    March 8, 2002
    Date of Event
    January 15, 2002
    Report Date
    February 28, 2002
    Manufacturer
    EUROMEDICAL INDUSTRIES SDN. BHD.
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    COMPLAIT WAS INITIALLY FORWARDED TO "ALLEGIANCE HEALTHCARE CORPORATION" WHO IS ONE OF EUROMEDICAL'S DISTRIBUTOR IN UNITED STATES. "EUROMEDICAL" THE MANUFACTURER OF THE DEVICES ONLY RECEIVED THE COMPLAINT FROM "ALLEGIANCE HEALTHCARE CORPORATION" IN JANUARY 2002.

    Description of Event or Problem · 1

    CATHETERS ARE BRITTLE AND CRACKING. TIP OF CATHETER BROKE OFF IN PATIENT'S BLADDER AND REQUIRED SURGICAL INTERVENTION. FURTHER INFORMATION RECEIVED FROM THE CUSTOMER INDICATES THAT THE UROLOGIST USED A CYSTOSCOPE IN HIS OFFICE TO REMOVE THE TIP OF THE CATHETER WHICH REMAINED IN THE PATIENT'S BLADDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEGIANCE SILICONE ELASTOMER COATED FOLEY CATHETER SILICONE ELASTOMER COATED KOD EUROMEDICAL INDUSTRIES SDN. BHD. PS518 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other