BEUDAMED
    FDA Adverse Event Summary report: N

    STERILE ASC T A PACK

    MDR report key: 867257 · Received May 30, 2007

    Report

    Report Number
    867257
    Date Received
    May 30, 2007
    Date of Event
    April 17, 2007
    Report Date
    May 30, 2007
    Manufacturer
    CARDINAL HEALTH MEDICAL PRODUCTS AND SERVICES
    Product Code
    GDY
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGEON USING SPONGE FOR TONSIL SURGERY AND TAIL ON SPONGE CAME OFF DURING PACKING. NO SPONGE RETAINED, HOWEVER THIS COULD HAVE BEEN A PROBLEM WHEN THE PHYSICIAN WENT TO REMOVE AND NOT ABLE TO DUE TO THE TAIL MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERILE ASC T A PACK SPONGE, SURGICAL GDY CARDINAL HEALTH MEDICAL PRODUCTS AND SERVICES * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *