BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLEY CATHETER, 2W STD SIL CH16

    MDR report key: 2935171 · Received January 28, 2013

    Report

    Report Number
    9611710-2013-00043
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    January 10, 2012
    Report Date
    January 10, 2012
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    KOD
    PMA / PMN Number
    K841544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS IDENTIFIED DURING OUR RETROSPECTIVE REVIEW ON COMPLAINTS FROM OUR FACILITY IN (B)(6). THIS IS RELATED TO ((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. REPORTED TO THE FDA ON (B)(6)2013. 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 IS BEING CREATED AS PART OF A FURTHER CORRECTION ACTION, RETROSPECTIVE REVIEW FOR 'PRIVATE LABEL' PRODUCT ((B)(4)). THIS COMPLAINT WAS REC'D BY (B)(6) ON (B)(6) 2012 FROM (B)(6) FOR PRODUCT 2 WAY SILICONISED FOLEY CATHETER SIZE 16X30. CUSTOMER COMPLAINING: " HARD TO EMPTY THE BALLOON".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37768 FOLEY CATHETER, 2W STD SIL CH16 UROLOGICAL CATHETER AND ACCESSORIES KOD UNOMEDICAL SDN BHD 812116 402119R001

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention