BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLEY CATHETER, 2W STD SEC CH16

    MDR report key: 2932406 · Received January 24, 2013

    Report

    Report Number
    9611710-2013-00020
    Event Type
    Malfunction
    Date Received
    January 24, 2013
    Date of Event
    February 10, 2012
    Report Date
    February 10, 2012
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    KOD
    PMA / PMN Number
    K770256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 (FDA AUDIT-OBSERVATION #7 FROM (B)(4)). 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 FAILS TO DEFLATE. REPORTED TO THE FDA ON (B)(6) 2013. NOTE: THE ACTUAL DATE OF EVENT (A3) IS UNKNOWN, SO THE DATE USED WAS THE DATE WAS 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 (FDA AUDIT-OBSERVATION #7). THIS COMPLAINT WAS RECEIVED BY (B)(6) 2012 FROM (B)(6) FOR PRODUCT 2 WAY STANDARD SEC FOLEY CATHETER SIZE 16X10. CUSTOMER COMPLAINING: "IMPOSSIBLE TO DEFLATE THE BALLOON."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34668 FOLEY CATHETER, 2W STD SEC CH16 UROLOGICAL CATHETER AND ACCESSORIES KOD UNOMEDICAL SDN BHD E210-16TN UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention