BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLEY CATHETER, 3W STD SLC CH22

    MDR report key: 3140026 · Received May 29, 2013

    Report

    Report Number
    9611710-2013-00254
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 24, 2013
    Report Date
    May 3, 2013
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    EZL
    PMA / PMN Number
    K944007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON AVAILABLE INFORMATION, OUR MEDICAL DETERMINATION IS THAT THIS MALFUNCTION IS SERIOUS: BECAUSE SOMETIMES, A SURGICAL INTERVENTION IS NEEDED TO REMOVE A CATHETER WHOSE BALLOON HAS FAILED/ DIFFICULT TO DEFLATE. IF FORCIBLY REMOVED WITH THE BALLOON STILL FULLY INFLATED, THERE IS A RISK OF SERIOUS INJURY TO THE SOFT TISSUES OF THE URETHRA. AN ANALYSIS ON THE RETURNED SAMPLE SHOWED THAT IT MET SPECIFICATION. NO SIGN OF DIFFICULTY DURING DEFLATION OF THE BALLOON COULD BE OBSERVED AS WATER DRAINED COMPLETELY FROM THE BALLOON WITHIN 56.4 SECONDS AND THUS CONSIDERED ACCEPTABLE AS PER LAB TEST SPECIFICATION. REPORTED TO THE FDA ON (B)(4) 2013.

    Description of Event or Problem · 1

    COMPLAINT DESCRIPTION: DIFFICULT DEFLATION IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237467 FOLEY CATHETER, 3W STD SLC CH22 UROLOGICAL CATHETER AND ACCESSORIES EZL UNOMEDICAL SDN BHD MM55182230 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1