BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTI-MED

    MDR report key: 35443 · Received July 2, 1996

    Report

    Report Number
    35443
    Event Type
    Injury
    Date Received
    July 2, 1996
    Date of Event
    April 4, 1996
    Report Date
    April 10, 1996
    Manufacturer
    ULTI-MED INTL., INC.
    Product Code
    GDY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN NOTED LARGE AMOUNTS OF LINT ON HER GLOVES AND IN THE PT'S WOUND AFTER USING THE LAP SPONGE INTRA-OP. INCIDENT NECESSITATED WOUND IRRIGATIONS AND SOME CONCERNS THAT THE PT COULD RETURN WITH INFECTION OR STERILE ABSCESS. TO DATE, HOWEVER, NO UNTOWARD EVENTS HAVE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTI-MED LAP SPONGE GDY ULTI-MED INTL., INC. * 8489-8494

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention