BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAYLOR CHIN IMPLANT

    MDR report key: 32401 · Received April 26, 1996

    Report

    Report Number
    MW1008978
    Event Type
    Injury
    Date Received
    April 26, 1996
    Date of Event
    October 24, 1992
    Report Date
    April 25, 1996
    Manufacturer
    MCGHAN MEDICAL CORP.
    Product Code
    FWP
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR WAS SPITTING SUTURES, SHE HAD INTRAORAL BLEEDING AND HAD TO CLEAN WITH PEROXIDE SOLUTION. AS TIME PROGRESSED, SHE HAD CHIN PAIN AND TENDERNESS (MORE ON THE RIGHT SIDE). SHE ALSO EXPERIENCED A TINGLING SENSATION IN HER FACE AND EXTREMITIES, COLD HANDS AND FEET, DRY EYES AND MOUTH, SIGNIFICANT WEIGHT LOSS, AND ANTERIOR AND POSTERIOR CERVICAL AND BILATERAL AXILLARY AND INGUINAL LYMPHADENOPATHY. SHE HAD A BLOOD TEST AND SHE FOUND OUT THAT SHE HAD SILICONE INTRABODIES; "BIG EYE"; IMMUNE DISREGULATION, MECHANISM DISORDERS THAT CAUSED HER TO HAVE SILICONE MATERIAL. AUTOIMMUNE DISEASE, AND THYROID PROBLEMS. THE SALIVARY GLANDS HAD FOREIGN BODY GIANT CELL GRANULATION TISSUE DESTRUCTION FROM THE SILICONE IN ALL 3 LOCATIONS (RIGHT, LEFT, AND CHIN). HER IMMUNE SYSTEM IS "GUARDED" (WILL BE LIKE THIS FOR THE REST OR HER LIFE). SHE IS ALLERGIC TO SYNTHETIC MATERIALS SUCH AS SILICONE AND PLASTIC. SHE HAD ROLLER LIP IMCOMPETENCE AND PTOSIS TO THE DEGREE WHERE SHE IS UNABLE TO CLOSE HER MOUTH AND TOUCH HER UPPER AND LOWER LIPS TOGETHER WITHOUT SEVERE PAIN. SHE HAS PROBLEMS EATING, TALKING (PRONOUNCING WORDS) AND SHE IS VERY SENSITIVE TO HOT AND COLD WHERE THE IMPLANT ANGLES ARE LOCATED. ON 3/93 SHE HAD A SOFT TISSUE GENIOPLASTY. HER PAIN GOT WORSE AND SHE WAS HAVING PROBLEMS SUCH AS CHRONIC FATIGUE, MEMORY PROBLEMS AND VISUAL DISTURBANCES, DISORIENTATION AND PROBLEMS WITH COGNITIVE FUNCTIONS. (ALSO SEE 1008976, 1008977)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAYLOR CHIN IMPLANT Implant CHIN IMPLANT FWP MCGHAN MEDICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Disability