BEUDAMED
    FDA Adverse Event Other Summary report: N

    GENERAL SURGERY

    MDR report key: 1914095 · Received December 2, 2010

    Report

    Report Number
    1417592-2010-00072
    Event Type
    Other
    Date Received
    December 2, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 23, 2010
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    GDY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THERE WERE 6 LAP SPONGES IN THE CUSTOM PACK INSTEAD OF 5. TWO OF THE SPONGES WERE ENVELOPED TOGETHER. IT APPEARED THAT THERE WERE FIVE, ONE WAS IDENTIFIED AS "FLUFFIER" THAN THE REST. IT WAS NOT DISCOVERED UNTIL LATER IN THE SURGICAL PROCEDURE. IT RESULTED IN A RE-EXPLORATION OF THE SURGICAL SITE, POST OPERATIVE X-RAY, EXTENDED ANESTHESIA TIME AND AN INCORRECT SURGICAL COUNT. THIS IS A DEROYAL PRODUCT. THE LAP SPONGES COME PRECOUNTED AND BANDED FROM DEROYAL. THIS ISSUE HAS BEEN FORWARDED TO THE VENDOR FOR FURTHER INVESTIGATION AND DETERMINATION OF THE NEED FOR ANY CORRECTIVE ACTION. DUE TO THE REPORTED INCIDENT, THIS MEDWATCH IS BEING FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO LAP SPONGES WERE ENVELOPED TOGETHER AND NOT IDENTIFIED UNTIL LATER IN THE SURGICAL PROCEDURE. IT RESULTED IN ADD'L SURGICAL TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENERAL SURGERY DEROYAL LAP SPONGE WITHIN PACK GDY MEDLINE INDUSTRIES, INC. DYNJ19808J 10HD1678

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention