BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2792345 · Received September 17, 2012

    Report

    Report Number
    2792345
    Event Type
    Malfunction
    Date Received
    September 17, 2012
    Date of Event
    August 29, 2012
    Report Date
    September 17, 2012
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    LRO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    IN A PREP PACK WHICH COMES SEPARATE FROM THE SURGICAL DRAPES DEBRIS WAS FOUND IN THE SPONGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * SURGICAL PACK, CATARACT LRO CARDINAL HEALTH 200, LLC * 864298

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR