BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTINE RIBBON

    MDR report key: 1663472 · Received April 16, 2010

    Report

    Report Number
    3003644133-2010-00003
    Event Type
    Injury
    Date Received
    April 16, 2010
    Date of Event
    March 1, 2010
    Report Date
    March 18, 2010
    Manufacturer
    COAPT SYSTEMS, INC.
    Product Code
    GAN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL LOT #: 02667, EXPIRATION DATE: 09/30/2011, MANUFACTURE DATE: 10/2009. THE EXPLANTED DEVICES WERE NOT RETURNED TO THE MANUFACTURER, THEREFORE AN EVALUATION TO DETERMINE FAILURE MODE COULD NOT BE CONDUCTED. THE BATCH RECORD FOR THESE LOTS HAVE BEEN REVIEWED, WHICH CONTAIN NO ABNORMAL MANUFACTURING EVENTS. THE COMPLAINT RATE FOR EACH LOT IS NOT ABNORMAL. THERE IS A LOW OCCURRENCE RATE OF DEVICE BREAKAGE RELATED TO THIS DEVICE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE PHYSICIAN IMPLANTED TWO DEVICES (B)(6) 2010. ON (B)(6) 2010, THE PHYSICIAN PERFORMED AN EXPLORATION SURGERY TO ASSESS THE IMPLANTED DEVICES. THE PHYSICIAN REMOVED TWO PARTIAL DEVICES AND IMPLANTED TWO REPLACEMENT DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTINE RIBBON ABSORBABLE SURGICAL SUTURE GAN COAPT SYSTEMS, INC. 13005 02457

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention