BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINER EYE PACK

    MDR report key: 210539 · Received February 17, 1999

    Report

    Report Number
    MW1015709
    Event Type
    Malfunction
    Date Received
    February 17, 1999
    Date of Event
    January 7, 1999
    Report Date
    February 9, 1999
    Manufacturer
    MEDICAL CONCEPTS DEVELOPMENT, INC.
    Product Code
    HMT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT ADMITTED FOR RECESS RECTUS BILATERAL EYES USING SURGICAL DRAPE WITH ADHESIVE. WHEN THE DRAPES WERE REMOVED THE CHILD'S EYELASHES AND EYEBROWS WERE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINER EYE PACK Implant CUSTOM PACK : DRAPE FOR EYE SURGERY HMT MEDICAL CONCEPTS DEVELOPMENT, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Other