BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KERLIX DISP LAP SPONGE

    MDR report key: 378712 · Received February 20, 2002

    Report

    Report Number
    1018120-2002-00001
    Event Type
    Malfunction
    Date Received
    February 20, 2002
    Date of Event
    February 1, 2002
    Report Date
    February 19, 2002
    Manufacturer
    AUGUSTA
    Product Code
    EFQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO TYCO HEALTHCARE ON 2/19/2002 THAT 2 SPONGES, USED IN THE OR CONTAINED FOREIGN OBJECTS. THE PHYSICIAN FOUND A RED RUBBER LIKE RING INSIDE THE SURGICAL SITE. ANOTHER RING LIKE INSIDE THE SURGICAL SITE. ANOTHER RING LIKE OBJECT WAS FOUND INSIDE A LAP SPOUNGE. THE SPONGE WAS REMOVED FROM THE SURGICAL FIELD.

    Description of Event or Problem · 1

    IT WAS REPORTED TO TYCO HEALTHCARE ON 02/19/02 THAT 2 SPONGES, USED IN THE OR, CONTAINED FOREIGN OBJECTS. THE PHYSICIAN FOUND A RED RUBBER LIKE RING INSIDE THE SURGICAL SITE. ANOTHER RING LIKE OBJECT WAS FOUND INSIDE A LAP SPONGE. THE SPONGE WAS REMOVED FROM THE SURGICAL FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KERLIX DISP LAP SPONGE SPONGE EFQ AUGUSTA * GH3905AG

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other