BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BULKHEAD ADAPTER

    MDR report key: 3145180 · Received May 30, 2013

    Report

    Report Number
    1213649-2013-00020
    Event Type
    Malfunction
    Date Received
    May 30, 2013
    Date of Event
    April 16, 2013
    Report Date
    May 16, 2013
    Manufacturer
    CADENCE INC.
    Product Code
    DWO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THE ADAPTER DID NOT HAVE A THROUGH-HOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238540 BULKHEAD ADAPTER ADAPTER DWO CADENCE INC. 6143 W002470/1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other