BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTFORM FACIAL IMPLANT

    MDR report key: 248689 · Received November 2, 1999

    Report

    Report Number
    2027148-1999-00210
    Event Type
    Injury
    Date Received
    November 2, 1999
    Date of Event
    June 24, 1999
    Report Date
    November 2, 1999
    Manufacturer
    TISSUE TECHNOLOGIES, INC.
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT IMPLANTED IN NASOLABIAL FOLDS 1999. ONSET 1999 OF SYSTEMIC SYMPTOMS, LAB TEST ABNORMALITY, ABDOMINAL PAIN, EDEMA, NUMBNESS, TACHYCARDIA, COGNITIVE DISTURBANCE, JOINT ACHES, PARANOIA, ANXIETY REACTION, COLD EXTREMITIES, SWEATING. PT TREATED WITH BENADRYL 05/06/1999, PREDNISONE 06/01/1999 AND CORTISONE 06/22/1999. THE IMPLANT WAS EXPLANTED 1999. SOFTFORM LITERATURE STATES THE BODY MAY HAVE A HYPERSENSITIVITY OR ALLERGIC REACTION TO THE MATERIAL WHICH WOULD REQUIRE ITS REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTFORM FACIAL IMPLANT Implant SOFTFORM FTL TISSUE TECHNOLOGIES, INC. NA K03638/98C421A

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention SALINE BREAST IMPLANTS (TO 1999).| ORAL CONTRACEPTIVE (TO 04/15/1999),