BEUDAMED
    FDA Adverse Event Other Summary report: N

    10MM X 4CM NEURAWRAP

    MDR report key: 1310044 · Received February 6, 2009

    Report

    Report Number
    1121308-2009-00007
    Event Type
    Other
    Date Received
    February 6, 2009
    Date of Event
    July 25, 2008
    Report Date
    September 6, 2009
    Manufacturer
    INTEGRA LIFESCIENCES
    Product Code
    FTM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT APPROX. SIX MONTHS POST OP, THE PT IS STILL HAVING PAIN IN THE TARSAL TUNNEL. A NEURAWRAP WAS USED TO WRAP THE NERVE. INTEGRA HAS REQUESTED IN WRITING ADDITIONAL CLINICAL INFO. FROM THE REPORTER. NEURAWRAP NW740, LOT#: 1072295 WAS ALSO USED. SEE MFR. REPORT#: 1121308-2009-00006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 10MM X 4CM NEURAWRAP NEURAWRAP PROTECTOR FTM INTEGRA LIFESCIENCES 1072389

    Patients

    Seq Age Sex Outcome Treatment
    1 Other