BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTFORM FACIAL IMPLANT

    MDR report key: 372972 · Received January 16, 2002

    Report

    Report Number
    2027148-2001-00020
    Event Type
    Injury
    Date Received
    January 16, 2002
    Date of Event
    May 9, 2001
    Report Date
    January 16, 2002
    Manufacturer
    TISSUE TECHNOLOGIES, INC.
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FIRST IMPLANTING 1998 IN VERMILLION BORDER. ONSET OF IMPLANT SHORTENING DATE UNK. ADDITIONAL SOFTFORM IMPLANTED 2001. IMPLANT(S) EXPLANTED 2001. DR REPORTED THAT HE EXPECTS THIS CASE TO EVENTUALLY BECOME A LAWSUIT AND ON THE DEVICE OF HIS LEGAL COUNSEL HE COULD ONLY PROVIDE THE DATES OF SURGERY AND DEVICE LOT NUMBERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTFORM FACIAL IMPLANT SOFTFORM FTL TISSUE TECHNOLOGIES, INC. NA K03977/98K251A

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention