BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCU-GUARD

    MDR report key: 294271 · Received August 31, 2000

    Report

    Report Number
    2183620-2000-00010
    Event Type
    Injury
    Date Received
    August 31, 2000
    Date of Event
    July 14, 2000
    Report Date
    August 31, 2000
    Manufacturer
    BIO-VASCULAR, INC.
    Product Code
    MTZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 2000, PT RECEIVED AN OCU-GUARD ORBITAL IMPLANT WRAP TO REPAIR A PREVIOUSLY PLACED VICRYL-WRAPPED HYDROXYAPATITE SPHERE, WHICH HAD EXTRUDED AFTER ENUCLEATION. ON 07/14/2000, THE PT PRESENTED WITH CONJUNCTIVAL DEHISCENCE OVER THE OCU-GUARD. PER THE SURGEON'S REPORT, THE DEHISCENCE HAS BEEN ATTRIBUTED TO MODERATE TRAUMA SECONDARY TO TWO PREVIOUS SURGERIES. TO DATE, THE OCU-GUARD HAS NOT BEEN EXPLANTED. THE AREA IS IMPROVING, THE EXPOSED AREA IS REDUCING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Hospitalization| R