BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PADGETT ELECTRO-DERMATOME MODEL B 110 V

    MDR report key: 1005419 · Received February 29, 2008

    Report

    Report Number
    3003418325-2008-00004
    Event Type
    Malfunction
    Date Received
    February 29, 2008
    Report Date
    February 29, 2008
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    GFD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INCIDENT. CORRESPONDENCE SHOULD BE SENT TO: INTEGRA LIFESCIENCES CORPORATION. 311 ENTERPRISE DRIVE. PLAINSBORO, NJ 08536. ATTN: CORPORATE COMPLAINT COORDINATOR.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED, THAT THE DEVICE IS SKIPPING AND IS UNABLE TO TAKE GOOD QUALITY GRAFTS. IT WAS REPORTED THAT DURING A PROCEDURE, AFTER THE INITIAL GRAFT FROM THE HAND WAS TAKEN AND WAS DEEMED OF A POOR QUALITY; ANOTHER ATTEMPT TO RETRIEVE A CLEAN GRAFT WAS MADE; HOWEVER, BECAUSE THE DEVICE KEPT SKIPPING THE SECOND GRAFT WAS ALSO OF A POOR QUALITY. THE FACILITY REPORTED USING A NEW BLADE DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PADGETT ELECTRO-DERMATOME MODEL B 110 V DERMATOME GFD INTEGRA LIFESCIENCES CORPORATION 3539-250

    Patients

    Seq Age Sex Outcome Treatment
    1