BEUDAMED
    FDA Adverse Event Other Summary report: N

    LAP SPONGE

    MDR report key: 2818482 · Received October 26, 2012

    Report

    Report Number
    1417592-2012-00092
    Event Type
    Other
    Date Received
    October 26, 2012
    Date of Event
    September 24, 2012
    Report Date
    October 23, 2012
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    EFQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT DURING AN OPEN HEART SURGICAL PROCEDURE, A LAP SPONGE WAS NOTED TO BE FALLING APART IN THE CHEST CAVITY. PIECES WERE REMOVED AND THE SURGICAL SITE WAS IRRIGATED. NO FURTHER TREATMENT WAS INITIATED AND NO OTHER COMPLICATIONS NOTED. THE SAMPLE WAS RETURNED AND EVALUATED. IT WAS SEVERELY SOILED WITH BLOOD. HOLES WERE NOTED IN THE LAP SPONGE. THE EDGES OF THE HOLES WERE SOMEWHAT SMOOTH AND HAD THE APPEARANCE OF BEING CUT RATHER THAN TORN OR RIPPED. NO OTHER SIMILAR INCIDENT HAS BEEN REPORTED TO US. A ROOT CAUSE WAS NOT DETERMINED, BUT WE CANNOT RULE OUT THE POSSIBILITY THAT THE DAMAGE TO THE LAP SPONGE MAY HAVE BEEN CAUSED BY AN INSTRUMENT DURING THE SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE, THE LAP SPONGE WAS NOTED TO BE FALLING APART IN THE SURGICAL SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP SPONGE EFQ MEDLINE INDUSTRIES, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention