BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTFORM FACIAL IMPLANT

    MDR report key: 141690 · Received December 30, 1997

    Report

    Report Number
    2939859-1997-00303
    Event Type
    Injury
    Date Received
    December 30, 1997
    Date of Event
    January 1, 1997
    Report Date
    December 16, 1997
    Manufacturer
    TISSUE TECHNOLOGIES, INC
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED A PT WHO WAS IMPLANTED ON 10/17/1997 IN THE RIGHT AND LEFT NASOLABIAL FOLDS. THE PROCEDURES WERE UNEVENTFUL AND THE PT WAS DIRECTED TO APPLY COLD COMPRESSES TO BOTH SITES AND SLEEP WITH HIS HEAD ELEVATED FOR THREE DAYS. ON 10/22/1997 THE PT HAD NO COMPLAINTS. THE PHYSICIAN REMOVED THE SUTURES; HE NOTED THAT THE IMPLANTS APPEARED TO BE IN CORRECT POSITION, THE INCISIONS APPEARED TO BE HEALING WELL, AND THERE WAS NO FACIAL SWELLING, BRUISING, INFLAMMATION OR DRAINAGE. ON 11/19/1997 THE PHYSICIAN NOTED THAT THE RIGHT NASOLABIAL ENTRANCE INCISION APPEARED LUMPY AND WAS DRAINING FLUID (EXACT NATURE AND DATE OF ONSET NOT RECORDED). HE INCISED AND CLEANED THE SITE AND LEFT IT OPEN TO DRAIN. ON APPROXIMATELY 11-21-1997 THE PT REPORTED A CONTINUATION OF MINIMAL DRAINAGE, SLIGHT LUMPINESS AND SOME DISCOMFORT AT THE AFFECTED SITE. THE PHYSICIAN DIRECTED THE PT TO CONTINUE ON KEFLEX. ON 12/3/1997 THE PHYSICIAN OBSERVED IMPROVED BUT CONTINUED OZZING INFLAMMATION AND LUMPINESS AND SOME DISCOMFORT AT THE AFFECTED SITE. THE PHYSICIAN DIRECTED THE PT TO CONTINUE ON KEFLEX. ON 12/3/1997 THE PHYSICIAN OBSERVED IMPROVED BUT CONTINUED OOZING, INFLAMMATION AND LUMPINESS AT THE AFFECTED SITE. HE NOTED THAT THE IMPLANT DID NOT APPEAR TO SETTLE DOWN AND SEAT ITSELF IN THE FOLD, AND THAT IT APPEARED TO HAVE SHRUNK. HE DID NOT NOTE WHETHER HE BELIEVED THE IMPLANT WAS EXTRUDED. HE INJECTED THE SITE WITH KENALOG AND DIRECTED THE PT TO CONTINUE ON KEFLEX. ON 12/16/1997 THE PHYSICIAN REMOVED THE RIGHT NASOLABIAL IMPLANT DUE TO CONTINUED DRAINAGE FROM THE SITE AND PRESCIBED ORAL AUGMENTIN. ON 12/23/1997, THE EXPLANT WAS RETURNED TO THE DISTRIBUTOR FOR ANALYSIS. AFTER THE ANALYSIS IS COMPLETE, A REPORT WILL BE FORWARDED TO THE MFR. DESCRIPTIONS OF ALL PT PROBLEM CODES: WOUND DRAINAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTFORM FACIAL IMPLANT Implant SOFTFORM FTL TISSUE TECHNOLOGIES, INC NA 97J191A

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention COLLAGEN TEST IMPLANT (10/17/1997 TO 10/17/1997).