BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2792377 · Received September 17, 2012

    Report

    Report Number
    2792377
    Event Type
    Malfunction
    Date Received
    September 17, 2012
    Date of Event
    September 4, 2012
    Report Date
    September 17, 2012
    Product Code
    OJK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    OCCULOPLASTY PACK PLAIN SPONGE HAD DEBRIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * SURGICAL PACK, CUSTOM, OCCULOPLAST OJK * 855712

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR