BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONTOUR THREAD OR CONTOUR THREADS

    MDR report key: 1172675 · Received September 16, 2008

    Report

    Report Number
    2522801-2008-00036
    Event Type
    Other
    Date Received
    September 16, 2008
    Date of Event
    January 1, 2006
    Report Date
    September 16, 2008
    Manufacturer
    SURGICAL SPECIALTIES CORP/ (DBA ANGIOTECH)
    Product Code
    GAP
    PMA / PMN Number
    K041593-MIDF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF EVENT IS ESTIMATED. BROW LIFT, NECK LIFT, BI-DIRECTIONAL MIDFACE CONTOUR THREAD. THE DEVICE WAS NOT RETURNED FOR EVAL. FURTHERMORE, THE PRODUCT CODE/LOT IS UNK. RESULTS: THE DEVICE WAS NOT RETURNED FOR EVAL. NO PRODUCT EVAL CAN BE PERFORMED.

    Description of Event or Problem · 1

    THE PT REPORTED THAT SHE UNDERWENT A CONTOUR THREAD PROCEDURE TWO (2) YEARS AGO. TWO (2) CONTOUR THREADS WERE PLACED ON EACH SIDE OF HER MID-FACE REGION BY DR. THE PT REPORTS THAT THE THREADS ON THE RIGHT SIDE OF HER FACE ARE OKAY. HOWEVER, THE THREADS ON THE LEFT SIDE OF HER FACE ARE PALPABLE, SORE AND LUMPY. DR. TRIED TO REMOVE THE PRODUCT TWO (2) MONTHS AFTER THE INITIAL PROCEDURE BUT WAS UNSUCCESSFUL. THE PT SOUGHT A SECOND OPINION FOR REMOVAL OF THE PRODUCT, AND WAS TOLD THAT SHE WOULD HAVE PERMANENT SCARRING. THE PT IS STILL SEEKING INFO REGARDING REMOVAL OF THE CONTOUR THREADS. NOTE: THE CONTOUR THREAD PRODUCT LINE IS NO LONGER MANUFACTURED OR SOLD BY SURGICAL SPECIALTIES CORPORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR THREAD OR CONTOUR THREADS BARBED THREAD WITH NEEDLE GAP SURGICAL SPECIALTIES CORP/ (DBA ANGIOTECH) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention NONE MADE AVAILABLE