BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HVLP MAGILL PAED KCC 4.0MM

    MDR report key: 5165296 · Received October 21, 2015

    Report

    Report Number
    9611710-2015-30720
    Event Type
    Malfunction
    Date Received
    October 21, 2015
    Report Date
    February 27, 2014
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    BTR
    PMA / PMN Number
    K951697
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONVATEC IS SUBMITTING THIS REPORT AS A RESULT OF ACTIVITIES RELATED TO CONVATEC REMEDIATION PROTOCOL (B)(4). ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT WILL BE FILED ON A SUPPLEMENTAL REPORT (MEDWATCH 3500A).

    Description of Event or Problem · 1

    COMPLAINANT REPORTS "FLASH AT THE END OF THE ADAPTER THERE APPEARS TO BE A POTENTIAL MOLDING ISSUE WITH THESE ADAPTERS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694897 HVLP MAGILL PAED KCC 4.0MM TUBE, TRACHEAL (W/WO CONNECTOR) BTR UNOMEDICAL SDN BHD 35113

    Patients

    Seq Age Sex Outcome Treatment
    1