BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODEL S HAND PIECE ONLY, DOES NOT INCLUDE HAND P

    MDR report key: 3287036 · Received August 12, 2013

    Report

    Report Number
    3004608878-2013-00152
    Event Type
    Injury
    Date Received
    August 12, 2013
    Report Date
    August 12, 2013
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    GFD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN REC'D FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    "FOR REPAIR". ADDITIONAL INFO WAS REQUESTED NUMEROUS TIMES BY INTEGRA. ON (B)(6) 2013 ADD'L INFO WAS REC'D BY INTEGRA: THERE WAS NO INJURY TO THE PT. THE INCIDENT OCCURRED DURING THE PT'S SURGERY; THE DONOR SITE WAS THE PT'S THIGH, A SECOND GRAFT WAS REQUIRED. THE SURGERY WAS DELAYED "MORE OR LESS 30 MINUTES". ADD'L INFO WAS REQUESTED BY INTEGRA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386519 MODEL S HAND PIECE ONLY, DOES NOT INCLUDE HAND P NA GFD INTEGRA LIFESCIENCES CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention