BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFORCE REINFORCEMENT MESH 6.5CM X 9CM

    MDR report key: 1963775 · Received January 11, 2011

    Report

    Report Number
    MW5019013
    Event Type
    Injury
    Date Received
    January 11, 2011
    Date of Event
    December 8, 2010
    Report Date
    January 11, 2011
    Manufacturer
    ORGANGENESIS INC.
    Product Code
    FTM
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE SURGEON REPORTED THAT A PT WHO HAD HAD WRIST SURGERY COULD NOT MOVE HIS FINGER. WHEN THE SURGEON DID A SECOND SURGERY HE FOUND THE GRAFT LOOKING "GEL" LIKE. HE FEELS THAT THE GRAFT BREAKS DOWN WHEN IT ENTERS THE BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFORCE REINFORCEMENT MESH 6.5CM X 9CM INFORCE FTM ORGANGENESIS INC. IF1000504A

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability