BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIRA

    MDR report key: 111587 · Received August 6, 1997

    Report

    Report Number
    111587
    Event Type
    Malfunction
    Date Received
    August 6, 1997
    Date of Event
    July 25, 1997
    Report Date
    July 28, 1997
    Manufacturer
    MIRA, INC.
    Product Code
    HQJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT HAD AN EXTRUDING SCLERAL BUCKLE AND CAME TO THE FACILITY FOR REMOVAL. UPON INSPECTION, THE BUCKLE APPEARED TO BE DECOMPOSED AND CAME OUT IN CHUNKS. A LARGE SCLERAL DEFECT WAS NOTED AS THE BUCKLE FRAGMENTS WERE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NIRA Implant MIRAGEL COMPONENT HQJ MIRA, INC. UNK *

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other