BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DOVER SILICONE CATHETER

    MDR report key: 2140652 · Received June 17, 2011

    Report

    Report Number
    1282497-2011-00011
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 20, 2011
    Manufacturer
    COVIDIEN
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2011. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2011 THAT A CUSTOMER HAD AN ISSUE WITH A URINARY CATHETER. THE CUSTOMER STATED THE BALLOON WOULD NOT DEFLATE AFTER INSERTION AND THE LUER LOCK BROKE OFF. THE CUSTOMER STATES SHE IS UNAWARE HOW THE CATHETER WAS REMOVED, THEY GENERALLY CUT THE INFLATION LUMEN AND REMOVE THE CATHETER. NO ADDITIONAL INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DOVER SILICONE CATHETER URINARY CATHETER KOD COVIDIEN 8887603085 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK