BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTELON TISSUE REINFORCEMENT

    MDR report key: 4925781 · Received July 16, 2015

    Report

    Report Number
    3010673515-2015-00002
    Event Type
    Injury
    Date Received
    July 16, 2015
    Date of Event
    June 16, 2015
    Report Date
    July 16, 2015
    Manufacturer
    INTERNATIONAL LIFE SCIENCES, D/B/A ARTELON
    Product Code
    FTL
    PMA / PMN Number
    K071887
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PT RECEIVED TISSUE REINFORCEMENT ON (B)(6) 2014 AT (B)(6) (LOT# 1002003780) AND AN ADDITIONAL SURGERY ON (B)(6) 2015 (LOT# 1110003853) TO IMPLANT ADDITIONAL TISSUE REINFORCEMENT. TISSUE REINFORCEMENT FROM (B)(6) 2015 REMOVED (B)(6) 2015 DUE TO INFECTION IDENTIFIED AS (B)(6). DEVICE HISTORY RECORDS FOR BOTH LOTS WERE REVIEWED AND ALL ACCEPTANCE CRITERIA WERE MET.

    Description of Event or Problem · 1

    REVISION SURGERY WAS PERFORMED DUE TO APPARENT INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463681 ARTELON TISSUE REINFORCEMENT TISSUE REINFORCEMENT FTL INTERNATIONAL LIFE SCIENCES, D/B/A ARTELON 31048 AND 31049 1002003780

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention