BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCU-GUARD

    MDR report key: 236199 · Received August 16, 1999

    Report

    Report Number
    2183620-1999-00017
    Event Type
    Injury
    Date Received
    August 16, 1999
    Date of Event
    December 7, 1998
    Report Date
    August 13, 1999
    Manufacturer
    BIO-VASCULAR, INC.
    Product Code
    MTZ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AFTER PREVIOUS EVISCERATION SURGERY, PATIENT COMPLAINED OF POOR FIT AND MOVEMENT OF OCULAR PROSTHESIS. OCU-GUARD (FLAT CONFIGURATION) WAS USED IN A SUBSEQUENT SURGERY TO WRAP THE ORBITAL IMPLANT IN 1999. PATIENT THEN PRESENTED WITH WOUND DEHISCENCE, INFLAMMATION AND BLEEDING. UNDERWENT REPAIR SURGERIES OF TWO DEHISCENCES ON 12/07/1998, 03/18/1999, AND 04/15/1999. RECEIVED A MUCOUS MEMBRANE GRAFT ON 06/09/1999. UNABLE TO WEAR OCULAR PROSTHESIS. PRESENTED WITH ANOTHER WOUND DEHISCENCE AND INFLAMMATION ON 08/03.1999.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCU-GUARD Implant ORBITAL IMPLANT WRAP MTZ BIO-VASCULAR, INC. NI OGSP-98B24

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization| R