BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDICAL UNKNOWN

    MDR report key: 2901474 · Received January 3, 2013

    Report

    Report Number
    8040412-2013-00026
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 12, 2012
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UNKNOWN IF SAMPLE IS AVAILABLE FOR EVAL, THEREFORE, INVESTIGATION IS INCOMPLETE.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: CUSTOMER REPORTED THE FOLLOWING: SHE RECEIVED A REPLACEMENT PRODUCT FOR THE RUSCH 22 FR 100% SILICONE TWO-WAY, 5 CC BALLOON INDWELLING FOLEY CATHETER AND STATED THAT THE "REPLACEMENT TWO PIECE, STIFF SILICONE CATHETER IS PAINFUL TO INSERT, CAUSES CONTINUOUS IRRITATION BETWEEN CHANGES, AND IS DIFFICULT TO REMOVE BECAUSE OF A RIDGE AT THE BASE OF THE BALLOON AFTER BALLOON DEFLATION. IT ALSO CAUSES BLEEDING WHEN THE CATHETER IS REMOVED BECAUSE OF THE RIDGE SCRAPING SENSITIVE AND FRAGILE TISSUE DURING THE DIFFICULT REMOVAL". IT IS UNKNOWN IF THIS IS A TELEFLEX PRODUCT. ADDITIONAL INFO WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2064 MEDICAL UNKNOWN SILICONE CATH UNKNOWN KOD TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention