BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAMPOLE ISOLATOR 10 MICROBIAL TUBE

    MDR report key: 17313 · Received September 2, 1994

    Report

    Report Number
    17313
    Event Type
    Injury
    Date Received
    September 2, 1994
    Date of Event
    August 19, 1994
    Report Date
    September 2, 1994
    Manufacturer
    WAMPOLE LABORATORIES
    Product Code
    JKA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE ATTEMPTING TO DRAW BLOOD SPECIMEN FOR CULTURE, PT EXPERIENCED EXTREME PAIN AT SITE. NEEDLE REMOVED. AREA BECAME VERY RED AND SWOLLEN, AND THERE WAS GREAT DISCOMFORT IN ENTIRE ARM. APPARENTLY ACCIDENTAL INJECTION OF CONTENTS OF MICROBIAL TUBE. ARM SEVERLY AFFECTED FOR SEVERAL DAYS WITH NAUSEA, PAIN, SWELLING, ERYTHEMA, UNABLE TO BEND ARM AT ELBOW FOR 3-5 DAYS. IT NOW APPEARS TO HAVE RESOLVED. PT HAD HEAT APPLIED, ANTIBIOTICS, EKG, PAIN MEDICATION, EXTENDED HOSPITALIZATION, AND INFECTIOUS DISEASE CONSULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WAMPOLE ISOLATOR 10 MICROBIAL TUBE TUBE FOR OBTAINING BLOOD CULTURE JKA WAMPOLE LABORATORIES

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R