BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCU-GUARD

    MDR report key: 232274 · Received July 16, 1999

    Report

    Report Number
    2183620-1999-00014
    Event Type
    Injury
    Date Received
    July 16, 1999
    Date of Event
    April 15, 1999
    Report Date
    July 16, 1999
    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

    PRIOR TO THE EVENT, THE SURGEON PERFORMED AN ENUCLEATION OPERATION ON 3/29/1999 ON THE PT'S LEFT EYE BECAUSE OF BLIND AND PAINTFUL EYE. A 20 MM ACRYLIC OCULAR IMPLANT SPHERE WRAPPED IN OCU-GUARD (ORBITAL IMPANT WRAP) WAS IMPLANTED FOLLOWING THE ENUCLEATION. THE PT HAD UNDERGONE MULTIPLE INTRAOCULAR PROCEDURES PRIOR TO THIS ENUCLEATION PROCEDURE. DESCRIPTION OF THE EVENT: 04/12/1999, THE PT PRESENTED WITH DEHISCENCE OF WOUND WITH EXPOSED OCU-GUARD (ORBITAL IMPLANT WRAP). ON 4/15/1999, THE SURGEON REMOVED THE OCU-GUARD WRAPPED IMPLANT. THE PT IS REPORTED TO BE IN EXCELLENT CONDITION AND DID NOT SUFFER ANY HARM DUE TO THIS COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCU-GUARD Implant ORBITAL IMPLANT WRAP MTZ BIO-VASCULAR, INC. OG2020SF 517937

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention