BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLEY CATHETERS

    MDR report key: 3901796 · Received May 8, 2014

    Report

    Report Number
    9611710-2014-00105
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    November 1, 2013
    Report Date
    April 11, 2014
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    KOD
    PMA / PMN Number
    K841544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON (B)(4) 2014 REPORTING THE COMPLAINANT STATED "THEY DIDN'T PIERCED THE BALLOON IN ORDER TO REMOVE IT. NO ISSUES ON THE PATIENT." ON (B)(4) 2014 ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL REPORTING THAT THE COMPLAINANT FURTHER STATED" YES, THE CATHETER WAS REPLACED BY ANOTHER ONE. BUT, STILL SOME LEAK ON THE SMALL BALLOON. SO THEY'VE INFLATED IT 2/3 MIL EVERY 15 DAYS. FINALLY, THEY'VE REMOVED THE CATHETER FROM THE PATIENT. NO, THERE IS NO COMPLAINT ON THE SECOND CATHETER." NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON (B)(4) 2014.

    Description of Event or Problem · 1

    IT WAS REPORTED "ON (B)(6) 2013, THE DOCTOR PUT THE FOLEY TUBE ON THE PATIENT. THE SAME DAY THEY HAVE REPORTED A LEAK ON THIS FOLEY TUBE. THE SMALL BALLOON WAS BLOWN UP AT 7CC AND BLOWN UP AGAIN AT 10CC. THE FOLEY TUBE WAS REMOVED ON (B)(6) 2013 DUE TO URINARY LEAK. THE SMALL BALLOON WAS PIERCED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280140 FOLEY CATHETERS CATHETER, UROLOGICAL 78KOD KOD UNOMEDICAL SDN BHD MM41151405 541031R001

    Patients

    Seq Age Sex Outcome Treatment
    1