BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMD-RITMED LAPAROTOMY SPONGES, PACK OF 5

    MDR report key: 1252465 · Received November 22, 2008

    Report

    Report Number
    1252465
    Event Type
    Malfunction
    Date Received
    November 22, 2008
    Date of Event
    October 22, 2008
    Report Date
    November 22, 2008
    Manufacturer
    AMD-RIITMED INC.
    Product Code
    GDY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE COUNTING LAP SPONGES DURING THE CASE, NURSE DISCOVERED THAT ONE OF THE LAPS WAS MISSING ITS LOOP. DOCTOR WAS IMMEDIATELY NOTIFIED. A SEARCH IN THE PATIENT AND IN AND AROUND THE FIELD WAS PERFORMED. THE MISSING LOOP WAS FOUND ON THE FLOOR. HOWEVER, SINCE WE COULD NOT BE SURE IF ANY OF THE LOOPS MIGHT BE IN THE PATIENT, AN INTRA-OP X-RAY WAS TAKEN. X-RAY WAS READ BY DOCTOR AND IT WAS DETERMINED TO BE NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMD-RITMED LAPAROTOMY SPONGES, PACK OF 5 SPONGES, SURGICAL, LAPAROTOMY GDY AMD-RIITMED INC. * 5331

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR