BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E REIN MUR 7.5MM 71-13265

    MDR report key: 5290033 · Received December 11, 2015

    Report

    Report Number
    9611710-2015-40023
    Event Type
    Malfunction
    Date Received
    December 11, 2015
    Report Date
    November 6, 2015
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    BTR
    PMA / PMN Number
    K962389
    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).

    Description of Event or Problem · 1

    IT WAS REPORTED FOREIGN SUBSTANCE IN THE PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820762 E REIN MUR 7.5MM 71-13265 TUBE, TRACHEAL (W/WO CONNECTOR) BTR UNOMEDICAL SDN BHD 61214075IJ 610338R001

    Patients

    Seq Age Sex Outcome Treatment
    1