BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEMADUCT 15FR, FULL DUCT W/TRO

    MDR report key: 547149 · Received October 1, 2004

    Report

    Report Number
    1423507-2004-00093
    Event Type
    Other
    Date Received
    October 1, 2004
    Date of Event
    August 30, 2004
    Report Date
    October 1, 2004
    Manufacturer
    CARDINAL HEALTH
    Product Code
    GBX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DR REPORTED THAT HE HAD A PT IN HIS OFFICE, POST OP IN 2004. PT HAD HAD AN AXILLARY DISSECTION AND A HEMADUCT DRAIN HAD BEEN PLACED AND BECAME OCCLUDED. DR. ALSO SAID THE PT HAD A SEROMA FLUID MASS AS A RESULT OF THE OCCLUSION. NO PRODUCT SAMPLE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMADUCT 15FR, FULL DUCT W/TRO WOUND DRAIN GBX CARDINAL HEALTH JP-HUR151 1040360

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention