BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREFORMED OCU-GUARD SUPPLE

    MDR report key: 208582 · Received January 29, 1999

    Report

    Report Number
    2183620-1999-00006
    Event Type
    Injury
    Date Received
    January 29, 1999
    Date of Event
    July 18, 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 06/19/1998, 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 07/18/1998, THE PT PRESENTED WITH EXPOSURE OF THE OCU-GUARD. THE SAME DAY, THE SURGEON RECLOSED TENON'S CAPSULE AND CONJUNCTIVA OVER THE HYDROXYAPETITE ORBITAL IMPLANT. HE DID NOT REMOVE THE OCU-GUARD WRAPPED ORBITAL IMPLANT. HE DOES NOT KNOW IF THE OCU-GUARD CONTRIBUTED TO THE PT'S COMPLICATION. THE SURGEON THEN IMPLANTED A VAULTED CONFORMER PROSTHESIS SO THE IMPLANT WOULD NOT RUB.

    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 52 YR Required Intervention