BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCU-GUARD SUPPLE

    MDR report key: 207370 · Received January 22, 1999

    Report

    Report Number
    2183620-1999-00002
    Event Type
    Injury
    Date Received
    January 22, 1999
    Date of Event
    October 5, 1998
    Report Date
    January 22, 1999
    Manufacturer
    BIO-VASCULAR, INC.
    Product Code
    MTZ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE SURGEON REPORTED THAT SHE PERFORMED A FRONTALIS SUSPENSION PROCEDURE USING OCU-GUARD SUPPLE ON 07/31/1998. THE PT EXPERIENCED SWELLING AND DRAINING OF YELLOW MATERIAL FROM INCISION SITE ON 10/05/1998. THIS WAS TREATED BY LANCING AND DRAINING THE INCISION. THE OCU-GUARD SUPPLE BEGAN TO EXTRUDE AND ON 11/02/1998 THE OCU-GUARD SUPPLE WAS EXPLANTED. THE SURGEON REPORTED THE PT ENCOUNTERED A POST-OPERATIVE INFECTION AND IT MAY NOT BE RELATED TO THE USE OF THE OCU-GUARD SUPPLE DEVICE. IT WAS REPORTED THAT NO HARM HAS COME TO THE PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention