BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-RAY DETECTABLE SURGICAL GAUGE SPONGE

    MDR report key: 64649 · Received January 23, 1997

    Report

    Report Number
    MW1010617
    Event Type
    Malfunction
    Date Received
    January 23, 1997
    Report Date
    December 30, 1996
    Manufacturer
    PROFESSIONAL MEDICAL PRODUCTS, INC.
    Product Code
    GDY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NM, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PACKAGE OF STERILE SURGICAL SPONGES WAS LABELED TO CONTAIN 10 SPONGES. THE PACKAGE CONTAINED ONLY 9 SPONGES. SPONGES ARE ACCOUNTABLE ITEMS DURING AND FOLLOWING SURGICAL PROCEDURES. MISPACKAGED ITEMS SUCH AS THIS CAN CAUSE PTS TO SPEND AN INORDINATE AMOUNT OF TIME IN THE OR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 X-RAY DETECTABLE SURGICAL GAUGE SPONGE X-RAY DETECTABLE SURGICAL GAUGE SPONGE GDY PROFESSIONAL MEDICAL PRODUCTS, INC. SPONGES-GAUZE *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other