BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAYTEK

    MDR report key: 2802485 · Received October 5, 2012

    Report

    Report Number
    2802485
    Event Type
    Malfunction
    Date Received
    October 5, 2012
    Date of Event
    October 3, 2012
    Report Date
    October 5, 2012
    Manufacturer
    CARDINAL HEALTH
    Product Code
    GDY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE XRAY OPAQUE STRING WAS VERY LOOSE IN THE SPONGE & STRINGS WERE COMING OFF THE SPONGE. THE SPONGES WERE NOT USED ON THE PATIENT. THE DEVICE PROBLEM WAS NOTED WHEN PREPARING FOR THE CASE.======================MANUFACTURER RESPONSE FOR RAYTEC SPONGE, STERILE MAJOR BASIN PACK (PER SITE REPORTER).======================AWAITING RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAYTEK GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE GDY CARDINAL HEALTH * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *