BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLEY CATHETER, 2W STD SEC CH30

    MDR report key: 2935167 · Received January 28, 2013

    Report

    Report Number
    9611710-2013-00041
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    November 16, 2012
    Report Date
    November 16, 2012
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    KOD
    PMA / PMN Number
    K770256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS IDENTIFIED DURING OUR RETROSPECTIVE REVIEW ON COMPLAINTS FROM OUR FACILITY IN (B)(4). BASED ON AVAILABLE INFO, OUR MED DETERMINATION IS THAT THIS MALFUNCTION IS SERIOUS: BECAUSE SOMETIMES, A SURGICAL INTERVENTION IS NEEDED TO REMOVE A CATHETER WHOSE BALLOON HAS FAILED TO DEFLATE. (B)(4). NOTE: THE ACTUAL DATE OF EVENT IS UNKNOWN, SO THE DATE USED WAS THE DATE WE BECAME AWARE.

    Description of Event or Problem · 1

    THIS COMPLAINT WAS REC'D BY (B)(4) ON (B)(6) 2012 FROM (B)(6) FOR PRODUCT 2 WAY STANDARD SEC FOLEY CATHETER SIZE 30X05. CUSTOMER COMPLAINING: " IT WAS IMPOSSIBLE TO DEFLATE THE BALLOON TO REMOVE THE CATHETER, WHICH HAD TO BE EXTRACTED BY FORCE. THE CATHETER WAS USED BY RECTAL TRACT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37955 FOLEY CATHETER, 2W STD SEC CH30 UROLOGICAL CATHETER AND ACCESSORIES KOD UNOMEDICAL SDN BHD QSM1301002 402159R001

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention