BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREFORMED OCU-GUARD SUPPLE

    MDR report key: 203636 · Received December 19, 1998

    Report

    Report Number
    2183620-1998-00011
    Event Type
    Injury
    Date Received
    December 19, 1998
    Date of Event
    November 20, 1998
    Report Date
    December 18, 1998
    Manufacturer
    BIO-VASCULAR, INC.
    Product Code
    MTZ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE SURGEON REPORTED THAT ON 10/15/1998, HE PERFORMED AN ENUCLEATION PROCEDURE DUE TO THE PT HAVING NO USEFUL VISION IN THAT EYE AND THE CONDITION OF THE EYE BEING PAINFUL TO THE PT. ON 11/20/1998, THE PT PRESENTED WITH EXPOSUE OF THE HYDROXYAPETITE ORBITAL IMPLANT, WHICH THE PREFORMED OCU-GUARD SUPPLE IS USED TO COVER. ON 12/16/1998, THE SURGEON PUT A DERMIS GRAFT OVER THE HYDROXYAPETITE ORBITAL IMPLANT. THE PREFORMED OCU-GUARD SUPPLE ORBITAL WRAP WAS NOT EXPLANTED. THE SURGEON DOES NOT ATTRIBUTE THE INCIDENT TO THE USE OF THE PREFORMED OCU-GUARD SUPPLE PRODUCT. THE CONDITION OF THE PT IS CURRENTLY STABLE.

    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 31 YR Required Intervention