BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCU-GUARD

    MDR report key: 221498 · Received April 28, 1999

    Report

    Report Number
    2183620-1999-00012
    Event Type
    Injury
    Date Received
    April 28, 1999
    Date of Event
    January 11, 1999
    Report Date
    April 28, 1999
    Manufacturer
    BIO-VASCULAR, INC.
    Product Code
    HQX
    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 01/11/1999, HE PERFORMED AN ENUCLEATION PROCEDURE USING OCU-GUARD AS THE HYDROXYAPETITE ORBITAL IMPLANT WRAP TO TREAT THE PT FOR A BLIND, PAINFUL EYE. FOLLOWING THIS PROCEDURE, THE PT PRESENTED WITH EXPOSURE OF THE ORBITAL IMPLANT WRAP ACCOMPANIED BY EXCESSIVE DRAINAGE. THE SURGEON THEN REMOVED THE HYDROXYAPETITE IMPLANT AND REPLACED IT WITH A SILICONE SPHERE. SUBSEQUENTLY, THE PT PRESENTED WITH EXTRUSION OF THE IMPLANT AND THE SURGEON ALSO REMOVED THE OCU-GUARD ORBITAL IMPLANT WRAP. THE SURGEON STATED THAT THE PT EXPERIENCED A "PROBABLE ALLERGIC REACTION". THE PT IS HEALING FROM THE SURGERY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention