BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE PORT

    MDR report key: 14796 · Received May 13, 1994

    Report

    Report Number
    14796
    Event Type
    Injury
    Date Received
    May 13, 1994
    Date of Event
    April 23, 1994
    Report Date
    May 2, 1994
    Manufacturer
    INFUSAID CORP.
    Product Code
    LKK
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    A KIT IMPLANTED 4/7/94, HAD TO BE REMOVED AND REPLACED WITH ANOTHER UNIT. USE THIS NOTICE AS BOTH SMDA ALERT AND EXPLANTATION NOTICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPLANTABLE PORT Implant IMPLANTABLE PORT LKK INFUSAID CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention