BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEMALE 14/018CM/78 2C +

    MDR report key: 3983457 · Received July 7, 2014

    Report

    Report Number
    3005778470-2014-00040
    Event Type
    Malfunction
    Date Received
    July 7, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 4, 2014
    Manufacturer
    UNOMEDICAL S.R.O.
    Product Code
    KOD
    PMA / PMN Number
    K896729
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. IT WAS FURTHER REPORTED THE PRODUCTS ARE STILL WITHIN THEIR ORIGINAL PACKAGING. 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 JULY 3, 2014. NOTE: THE ACTUAL DATE OF EVENT IS UNKNOWN, SO THE DATE USED WAS THE DATE CONVATEC BECAME AWARE.

    Description of Event or Problem · 1

    IT WAS REPORTED COMPLAINANT STATED "FOLDED CATHETERS UPON RECEIPT; THE CATHETERS WERE FOLDED AND UNUSABLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394931 FEMALE 14/018CM/78 2C + CATHETER, UROLOGICAL, 78KOD KOD UNOMEDICAL S.R.O. 02017179 478510

    Patients

    Seq Age Sex Outcome Treatment
    1