BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2885806 · Received December 20, 2012

    Report

    Report Number
    2885806
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    December 13, 2012
    Report Date
    December 20, 2012
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    GDY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGEON WAS USING MEDLINE STERILE X-RAY DETECTABLE GAUZE SPONGES DURING FACELIFT OPERATION. THE MEDLINE STERILE X-RAY DETECTABLE GAUZE SPONGES WAS CONTINUOUSLY SHREDDING INTO THE INCISION SITE, CAUSING THE SURGEON TO CONSTANTLY REMOVE THE SHREDDED PIECES FROM THE OPERATIVE SITE. THE MEDLINE STERILE X-RAY DETECTABLE GAUZE SPONGES WERE SUBSTITUTED WITH ANOTHER MANUFACTURER'S PRODUCT. THE FACELIFT WAS COMPLETED WITHOUT FURTHER COMPLICATIONS. PATIENT TAKEN TO PACU IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * GAUZES, SPONGES, X-RAY DETECTABLE GDY MEDLINE INDUSTRIES, INC. * AR45058333379

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR