BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2980436 · Received February 22, 2013

    Report

    Report Number
    9611710-2013-00157
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    November 28, 2011
    Report Date
    December 5, 2011
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    KOD
    PMA / PMN Number
    K841544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CASE HAS BEEN REVIEWED, AND DEEMED A MALFUNCTION. BASED ON CURRENT INFO, RECURRENCE OF THIS MALFUNCTION WOULD LIKELY LEAD TO A SERIOUS ADVERSE EVENT BECAUSE MEDICAL INTERVENTION AND SOMETIMES SURGICAL INTERVENTION IS REQUIRED TO PREVENT SERIOUS INJURY. REPORTED TO FDA ON (B)(4), 2013.

    Description of Event or Problem · 1

    THIS COMPLAINT WAS IDENTIFIED DURING OUR RETROSPECTIVE REVIEW OF COMPLAINTS FROM OUR FACILITY IN (B)(6). THIS IS RELATED TO ((B)(4)). COMPLAINT RECEIVED AS FOLLOWS: "NO HARM OR INJURY TO PT. NON-DEFLATION WAS NOTED IN PRETESTING. THE DEFLATION OF THE BALLOON WAS DONE AFTER MULTIPLE TRIALS FOR ONE HOUR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77604 FOLEY CATHETER, 2W SOFT VALVE STD 5/10CC CH14 UROLOGICAL CATHETER AND ACCESSORIES KOD UNOMEDICAL SDN BHD MM51111410 403823R001

    Patients

    Seq Age Sex Outcome Treatment
    1