BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTFORM FACIAL IMPLANT

    MDR report key: 372992 · Received January 16, 2002

    Report

    Report Number
    2027148-2001-00021
    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

    ORIGINALLY PT HAD SOFTFORM IMPLANTS PLACED IN THE UPPER AND LOWER VERMILLION BORDERS IN 1998. PT HAD ADDITIONAL SOFTFORM IMPLANTS ADDED TO THE UPPER VERMILLION BORDER IN 2001. PT DEVELOPED AN INFECTION IN THE UPPER LIP AFTER THIS THAT WAS RESISTANT TO ALL ANTIBIOTICS PRESCRIBED BY THE IMPLANTING PHYSICIAN. BECAUSE THE PT WOULD NOT RESPOND TO ANTIBIOTIC THERAPY THE PT HAD ALL SOFTFORM IMPLANTS IN THE UPPER VERMILLION BORDER EXPLANTED 2001.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTFORM FACIAL IMPLANT SOFTFORM FTL TISSUE TECHNOLOGIES, INC NA K04420/99G361A

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention