BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTFORM FACIAL IMPLANT

    MDR report key: 189172 · Received September 25, 1998

    Report

    Report Number
    2027148-1998-00065
    Event Type
    Injury
    Date Received
    September 25, 1998
    Date of Event
    March 2, 1998
    Report Date
    September 25, 1998
    Manufacturer
    TISSUE TECHNOLOGIES, INC.
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT IMPLANTED INTO THE UPPER AND LOWER VERMILION BORDERS ON 02/23/1998. ONSET OF LOSS OF AUGMENTATION IN PERIORAL AREA 03/02/1998. IMPLANT EXPLANTED 09/03/1998.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTFORM FACIAL IMPLANT Implant SOFTFORM FTL TISSUE TECHNOLOGIES, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention KEFLEX (02/1998 TO 1998),| MASSAGE (02/23/1998 TO 02/28/1998).