BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTACTH

    MDR report key: 87700 · Received February 9, 1995

    Report

    Report Number
    87700
    Event Type
    Injury
    Date Received
    February 9, 1995
    Date of Event
    October 12, 1994
    Report Date
    November 4, 1994
    Manufacturer
    STRATO MEDICAL CORP
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PORT DOES NOT PERMIT BLOOD RETURN. FRACTURE NOTED APPROXIMATELY 8 CM FROM ITS TIP USUALLY WHERE IT TRANSGRESSES THE CLAVICLE AND FIRST RIB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORTACTH Implant * LJT STRATO MEDICAL CORP * 402504

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention