BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINER EYE PACK

    MDR report key: 210538 · Received February 17, 1999

    Report

    Report Number
    MW1015708
    Event Type
    Malfunction
    Date Received
    February 17, 1999
    Date of Event
    February 4, 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 WAS ADMITTED FOR RECESS "M.R.," ADVANCE "IR" BOTH EYES AND ACOVREVISION BOTH EYES, FINECTOMY "SO" POST BOTH EYES. STERILE MINI DRAPES PLACED ACROSS EYES, FOREHEAD, AND NOSE. WHEN THE DRAPES WERE REMOVED, MOST OF THE RIGHT EYEBROW WAS 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 1 YR Other