BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRAVON

    MDR report key: 118698 · Received June 27, 1997

    Report

    Report Number
    118698
    Event Type
    Injury
    Date Received
    June 27, 1997
    Date of Event
    April 24, 1997
    Report Date
    May 28, 1997
    Manufacturer
    DRAVON
    Product Code
    HRQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FOLLOWING A DONOR RBCP PROCEDURE WHILE BLOOD SAMPLES WERE BEING COLLECTED, AIR WAS NOTICED TO BE IN THE TUBING. DISPOSABLE HEMOSTATS HAD BEEN APPLIED. PT COMPLAINED OF ACHE IN CHEST AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRAVON DISPOSABLE PLASTIC HEMOSTAR HRQ DRAVON UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention HAEMONETICS MCST, MODEL 8150