BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLEY CATHETER, 2W SOFT VALVE STD 5/10CC CH14

    MDR report key: 2993039 · Received March 1, 2013

    Report

    Report Number
    9611710-2013-00207
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    July 19, 2012
    Report Date
    August 8, 2012
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    KOD
    PMA / PMN Number
    K841544
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT IS DEEMED SERIOUS AS IT REQUIRED MEDICAL/SURGICAL INTERVENTION TO REMOVE THE CATHETER WHOSE BALLOON HAD FAILED TO DEFLATE. IF FORCIBLY REMOVED WITH THE BALLOON FULLY INFLATED, THIS COULD HAVE RESULTED IN SERIOUS HARM TO THE PATIENT. FROM A CLINICAL PERSPECTIVE, A CAUSAL RELATIONSHIP BETWEEN THE CATHETER AND THIS EVENT IS DEEMED POSSIBLE. REPORTED TO THE FDA ON MARCH 1, 2013.

    Description of Event or Problem · 1

    THIS COMPLAINT WAS IDENTIFIED DURING OUR RETROSPECTIVE REVIEW OF COMPLAINTS FROM OUR FACILITY IN (B)(6). COMPLAINT RECEIVED AS FOLLOWS: ¿COMPLAINT DESCRIPTION: THE NON-DEFLATION IN USE WAS NOTED. EVENTUALLY THEY CONSULTED THE UROLOGIST TO REMOVE THE FOLEY BY USING THE GUIDEWIRE. NO HARM OR INJURY TO PATIENT.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89930 FOLEY CATHETER, 2W SOFT VALVE STD 5/10CC CH14 UROLOGICAL CATHETER AND ACCESSORIES KOD UNOMEDICAL SDN BHD MM51111410 405580R003

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention