BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCU-GUARD

    MDR report key: 207332 · Received January 20, 1999

    Report

    Report Number
    2183620-1999-00001
    Event Type
    Injury
    Date Received
    January 20, 1999
    Manufacturer
    BIO-VASCULAR, INC.
    Product Code
    HQX
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE SURGEON REPORTED THAT AFTER IMPLANTING AN OCU-GUARD PRODUCT, THE PT EXPERIENCED DEHISCENCE OF THE CONJUNCTIVA. THIS COMPLICATION OCCURRED IN JULY. HE THOUGHT IT MAY BE AN ALLERGY. THE OCU-GUARD DEVICE WAS EXTRUDING AND WAS EXPLANTED.

    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 UNKNOWN Required Intervention