BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHEMO-SITE

    MDR report key: 20555 · Received March 1, 1995

    Report

    Report Number
    20555
    Event Type
    Injury
    Date Received
    March 1, 1995
    Date of Event
    May 9, 1994
    Report Date
    May 23, 1994
    Manufacturer
    DEVICE LABS
    Product Code
    LLD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    68 YO PATIENT HAD IMPLANTATION OF A CHEMOPORT AS ANGIOACCESS FOR IV CHEMOTHERAPY IN FEBRUARY, 94. FUNCTIONING WELL UNTIL RECENTLY WHEN IRRIGATION PRODUCED SUBCUTANEOUS SWELLING BELOW LEFT CLAVICLE. CONTRAST STUDIES THROUGH PORT SHOWED TWO SEPARATE AREAS OF EXTRAVASATION. TO OR FOR REVISION OF PORT; CATHETER FOUND TO BE SHEARED OFF 5/20/94 REMOVAL OF SHEARED OFF PORTION OF CATHETER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHEMO-SITE Implant PORTA-CATH LLD DEVICE LABS PRODUCT # 350297 9306

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R