BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTFORM FACIAL IMPLANT

    MDR report key: 196941 · Received November 12, 1998

    Report

    Report Number
    2027148-1998-00105
    Event Type
    Injury
    Date Received
    November 12, 1998
    Date of Event
    April 1, 1998
    Report Date
    November 12, 1998
    Manufacturer
    TISSUE TECHNOLOGIES, INC.
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT IMPLANTED IN BOTH ORAL COMMISSURES, DATE UNKNOWN. EXPERIENCED LOSS OF CORRECTION IN PERIORAL AREA, DATE UNKNOWN. IMPLANT EXPLANTED 04/1998.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTFORM FACIAL IMPLANT Implant SOFTFORM FTL TISSUE TECHNOLOGIES, INC. NA K03567/98B021A

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention 2. PROCARDIA (FROM 05/23/1998)| 4. KEFLEX (03/24/1998 TO 03/29/1998).| 3. ZYPLAST IMPLANT (FROM 09/04/1997)| 1. SYNTHROID (FROM 05/23/1998)