BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E ENTRA MUR 8.5MM

    MDR report key: 5161731 · Received October 20, 2015

    Report

    Report Number
    9611710-2015-30849
    Event Type
    Malfunction
    Date Received
    October 20, 2015
    Report Date
    February 27, 2014
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    BTR
    PMA / PMN Number
    K951696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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). CONVATEC IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21CFR PART 803. 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

    IT WAS REPORTED THAT THERE WAS FOREIGN SUBSTANCE IN THE PACKAGE. THE PRODUCT WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692073 E ENTRA MUR 8.5MM TUBE, TRACHEAL (W/WO CONNECTOR) BTR UNOMEDICAL SDN BHD 61110085IJ 609697R001

    Patients

    Seq Age Sex Outcome Treatment
    1