BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONTOUR THREAD OR CONTOUR THREADS

    MDR report key: 1211537 · Received October 3, 2008

    Report

    Report Number
    2522801-2008-00039
    Event Type
    Other
    Date Received
    October 3, 2008
    Report Date
    October 3, 2008
    Manufacturer
    SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)
    Product Code
    NEW
    PMA / PMN Number
    K041593
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMPLANT DATE IS UNKNOWN. THE EXPLANT DATES ARE UNKNOWN. ONE (1) THREAD WAS REMOVED IN 2008. THE OTHER THREADS ARE ESTIMATED TO HAVE BEEN REMOVED IN 2008. BROW LIFT, NECK LIFT, BI-DIRECTIONAL MIDFACE CONTOUR THREAD. THE DEVICE WAS NOT RETURNED FOR EVALUATION. FURTHERMORE, THE PRODUCT LOT NUMBER IS UNKNOWN. RESULTS: THE DEVICE WAS NOT RETURNED FOR EVALUATION. NO PRODUCT EVALUATION CAN BE PERFORMED.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT A CONTOUR THREAD PROCEDURE INVOLVING HIS/HER BILATERAL MIDFACE. THE PATIENT EXPERIENCED EXTRUSION AND INFECTION AT THE CONTOUR THREAD SITES. THE PATIENT HAD THREE (3) TO FOUR (4) THREADS SURGICALLY REMOVED AND WAS GIVEN ORAL ANTIBIOTICS. NOTE: THE CONTOUR THREAD PRODUCT LINE IS NO LONGER MANUFACTURED OR SOLD BY SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention NONE MADE AVAILABLE.