BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIOPAQUE GAUZE

    MDR report key: 31370 · Received March 20, 1996

    Report

    Report Number
    MW4001107
    Event Type
    Malfunction
    Date Received
    March 20, 1996
    Report Date
    January 9, 1996
    Manufacturer
    PROFESSIONAL MEDICAL PRODUCTS, INC.
    Product Code
    GDY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    4 X 8 RADIOPAQUE GAUZE. THIS ITEM IS UNACCEPTABLE IN ITS PRESENT CONDITION. DUE TO THE UNCERTAIN STATUS OF THE PACKAGE'S STERILITY RPTR IS UNABLE TO TAKE THE CHANCES OF USING THESE ITEMS ON SURGICAL PROCEDURES THAT MAY CAUSE HARM TO PTS. RPTR WOULD LIKE TO GET THIS SERIOUS PROBLEM RESOLVED AS SOON AS POSSIBLE BEFORE MORE ARE SENT TO THE WAREHOUSE. FROM THE OUTSIDE OF THESE PACKAGES, THERE SEEMS TO BE SOME MILDEW OR BROWN SPOTS THAT APPEAR ON TOP OF THE PAPER SEAL. THIS QUESTIONABLE DAMAGE TO THESE ITEMS CAN ONLY POINT TO SOME TYPE OF BREAKAGE IN ITS GUARANTEED STERILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIOPAQUE GAUZE RADIOPAQUE GAUZE GDY PROFESSIONAL MEDICAL PRODUCTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 *