BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONTOUR THREAD OR CONTOUR THREADS

    MDR report key: 1514377 · Received October 22, 2009

    Report

    Report Number
    2522801-2009-00030
    Event Type
    Other
    Date Received
    October 22, 2009
    Date of Event
    December 1, 2006
    Report Date
    October 22, 2009
    Manufacturer
    SURGICAL SPECIALTIES CORP (DBA ANGIOTECH)
    Product Code
    GAW
    PMA / PMN Number
    K041593
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURE DATE AND THE EXPIRATION DATE OF THIS PRODUCT IS UNK. NO ITEM OR LOT INFO WAS AVAILABLE. ADDITIONAL INFO FOR G5: 510 (K) #'S FOR CONTOUR THREADS: K041593 - MIDFACE LIFT, K042856 - BROW LIFT. K050247 - NECK LIFT, K050548 - BI-DIRECTIONAL MIDFACE CONTOUR THREAD. METHOD: THE DEVICE WAS NOT RETURNED FOR EVAL. FURTHERMORE, THE PRODUCT LOT NUMBER IS UNK. RESULTS/CONCLUSIONS: THE DEVICE WAS NOT RETURNED FOR EVAL. NO PRODUCT EVAL CAN BE PERFORMED. (B)(4).

    Description of Event or Problem · 1

    THE DATE OF THE EVENT IS ESTIMATED: A PT OF (B)(6) (LASER AND VEIN, (B)(6)), REPORTED THAT SHE UNDERWENT A MIDFACE PROCEDURE ON (B)(6) 2006 WHERE 2-4 CONTOUR THREADS WERE PLACED ON EACH SIDE. THE PT IMMEDIATELY EXPERIENCED SEVERE PAIN IN THE TEMPORAL AREA, PALPABLE THREADS AND MULTIPLE SKIN BREAKOUTS ALONG THE PATH OF THE THREADS. APPROX SIX (6) MONTHS TO ONE (1) YEAR POST-OPERATIVE, SHE PRESENTED BACK TO THE DOCTOR COMPLAINING OF THESE SYMPTOMS AND ALSO INFORMED THE SURGEON THAT SHE WAS VERY DISSATISFIED WITH THE OUTCOME AND INQUIRED ABOUT HAVING THE THREADS REMOVED. THE SURGEON INFORMED THE PT THAT REMOVAL OF THE THREADS WOULD LEAVE SCAR TISSUE AND OFFERED FREE FILLER. THE PT'S LAST VISIT WITH THE SURGEON WAS IN 2007. PT CONTINUES TO TAKE AN OVER THE COUNTER PAIN RELIEVER TO MANAGE THE PAIN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other NONE MADE AVAILABLE