BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEMADUCT 15FR, FULL DUCT W/TRO

    MDR report key: 547154 · Received October 1, 2004

    Report

    Report Number
    1423507-2004-00092
    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
    OTHER

    Narratives

    Description of Event or Problem · 1

    DR. REPORTED THAT HE HAD A PT IN HIS OFFICE, POST OP, IN 2004. PT HAD HAD A MASTECTOMY AND 2 HEMADUCT DRAINS HAD BEEN PLACED AND BOTH BECAME OCCLUDED. THEY ALSO SAID THE PT HAD SOME SEROMA FLUID MASSES 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 1040176

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention