BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODEL S HAND PIECE ONLY, DOES NOT INCLUDE HAND P

    MDR report key: 1347158 · Received March 18, 2009

    Report

    Report Number
    3004608878-2009-00005
    Event Type
    Injury
    Date Received
    March 18, 2009
    Report Date
    March 18, 2009
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR

    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 ON THE REPORTED INFORMATION. IMPORTANT ORGANS WERE NOT IMPACTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING THE SAMPLING OF SKIN ON THE PATIENT'S ARM, THERE WAS A DEEP INJURY OF 4 CM WHICH WAS SUTURED BY MECHANIC STAPLES. IMPORTANT ORGANS WERE NOT IMPACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODEL S HAND PIECE ONLY, DOES NOT INCLUDE HAND P NA GEI INTEGRA LIFESCIENCES CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention