BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE 18X18 RF DETECT SPONGE

    MDR report key: 1081163 · Received July 23, 2008

    Report

    Report Number
    MW5007775
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    July 22, 2008
    Report Date
    July 23, 2008
    Manufacturer
    MEDLINE INDUSTRIES INC.
    Product Code
    GDY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING LEFT THORACOTOMY PROCEDURE, DR. REMOVED RF SPONGE FROM CHEST CAVITY. THE STRING FROM THE LAP SPONGE CAME APART FROM THE SPONGE ITSELF DURING REMOVAL. SPONGE WAS REMOVED FROM CAVITY. SPONGE WAS INSPECTED FOR RF POUCH AND FOUND TO BE INTACT. PACKAGING WAS OBTAINED FROM TRASH AND IDENTIFIED. PICTURE OBTAINED OF DETACHED STRING, SPONGE, RF POUCH W/ CHIP AND PACKAGING. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: SURGICAL SPONGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDLINE 18X18 RF DETECT SPONGE RF STERILE LAP SPONGE GDY MEDLINE INDUSTRIES INC.

    Patients

    Seq Age Sex Outcome Treatment
    1