BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONTOUR THREADS

    MDR report key: 978052 · Received January 7, 2008

    Report

    Report Number
    2522801-2008-00001
    Event Type
    Other
    Date Received
    January 7, 2008
    Report Date
    January 7, 2008
    Manufacturer
    SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)
    Product Code
    GAW
    PMA / PMN Number
    K050548
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PT REPORTING PROBLEM WOULD NOT SUPPLY HER PHYSICIAN'S NAME TO SURGICAL SPECIALTIES CORP (DBA ANGIOTECH) THEREFORE, WE WERE NOT ABLE TO VERIFY THE TRAINING OF THE PHYSICIAN OR CHECK THE DEVICE HISTORY RECORDS FOR THE PRODUCT USED ON THIS PT.

    Description of Event or Problem · 1

    PT REPORTED THAT THE PHYSICIAN PLACED 4 CONTOUR THREADS ON EACH SIDE OF HER FACE AND SHE LOOKS WORSE NOW THAN THEN WHEN SHE WENT IN FOR THE CONTOUR THREAD LIFT. PT STATED " I HAVE DIMPLES AS THEY CALL THEM; I CALL THEM SUNKEN PLACES ON BOTH SIDES OF MY FACE. I NEVER HAD THOSE BEFORE ON MY FACE. MY MOUTH HAS THE SAME WRINKLES I HAD BEFORE, I WENT IN, IF NOT WORSE." PT REQUIRED MULTIPLES SURGICAL INTERVENTIONS TO RELIEVE CHRONIC NERVE PAIN. PT HAD INFECTION WHICH REQUIRED TREATMENT WITH ANTIBIOTICS. PT HAD GORTEX REMOVED WHICH WAS CAUSING NERVE PAIN. GORTEX WAS USED INCONJUNCTION WITH CT PROCEDURE. PT WOULD NOT SUPPLY THE NAME OF THE PHYSICIAN THAT DID THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR THREADS CONTOUR THREADS GAW SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention