BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREFORMED OCU-GUARD SUPPLE

    MDR report key: 208592 · Received January 29, 1999

    Report

    Report Number
    2183620-1999-00004
    Event Type
    Injury
    Date Received
    January 29, 1999
    Date of Event
    June 19, 1998
    Report Date
    January 28, 1999
    Manufacturer
    BIO-VASCULAR, INC.
    Product Code
    MTZ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE SURGEON REPORTED THAT ON 05/15/1998, HE PERFORMED AN ENUCLEATION PROCEDURE USING PREFORMED OCU-GUARD SUPPLE AS THE ORBITAL IMPLANT WRAP TO TREAT THE PT FOR A BLIND, PAINFUL EYE. ON 06/19/1998, THE PT PRESENTED WITH EXPOSURE OF THE HYDROXYAPETITE ORBITAL IMPLANT, WHICH THE PREFORMED OCU-GUARD SUPPLE IS USED TO COVER. ON 10/22/1998, THE SURGEON RECLOSED TENON'S CAPSULE AND CONJUNCTIVA OVER THE HYDROXYAPETITE ORBITAL IMPLANT WHERE IT WAS EXPOSED. THE SAME RECLOSURE PROCEDURE WAS PERFORMED ON 11/02/1998. ON 11/11/1998, THE SURGEON REMOVED THE PREFORMED OCU-GUARD SUPPLE ORBITAL WRAP AND THE IMPLANT. THE SURGEON DOES NOT KNOW IF THE PREFORMED OCU-GUARD SUPPLE CONTRIBUTED TO THE COMPLICATION THAT HIS PT EXPERIENCED. THE PT IS CURRENTLY DOING WELL AFTER REPLACEMENT WITH AN ACRYLIC SPHERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREFORMED OCU-GUARD SUPPLE Implant ORBITAL IMPLANT WRAP MTZ BIO-VASCULAR, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention