BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FFB BL CO-BR 2 HC-5 IN 38" SUTURE

    MDR report key: 1713791 · Received May 28, 2010

    Report

    Report Number
    3004365956-2010-00067
    Event Type
    Malfunction
    Date Received
    May 28, 2010
    Date of Event
    April 22, 2010
    Report Date
    May 5, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GAM
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE WILL BE RETURNED TO INVESTIGATE. EVAL: METHOD - OTHER - DHR REVIEW PERFORMED. RESULTS - OTHER - BASED ON LACK OF LOT NUMBER, THE MOST RECENT DHR WAS REVIEWED AND NO ISSUES OR DISCREPANCIES RELATED TO THE COMPLAINT WERE DETECTED. CONCLUSIONS - OTHER - NO CORRECTIVE ACTIONS WERE INITIATED, BUT THE MFR WILL CONTINUE TO TRACK AND TREND FOR SIMILAR INCIDENTS.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: DURING A PATELLAR TENDON REPAIR THE SUTURE IN THIS COMPLAINT WAS USED. WHEN PT WENT BACK TO THE DOCTOR FOR A POST-OP VISIT, THE DOCTOR CHECKED THE KNEE AND FELT SOMETHING HAD "POPPED". THE KNEE WAS OPENED AND IT WAS DISCOVERED THE SUTURE HAD SEPARATED. THE PT HAD A REPAIR SURGERY AND THE SUTURE WAS REPLACED. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FFB BL CO-BR 2 HC-5 IN 38" SUTURE FORCE FIBER SUTURE GAM TELEFLEX MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1