BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PADGETT

    MDR report key: 2250786 · Received September 2, 2011

    Report

    Report Number
    2250786
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 25, 2011
    Report Date
    September 2, 2011
    Manufacturer
    INTEGRA LIIFESCIENCES CORPORATION
    Product Code
    GFD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN WAS PERFORMING SPLIT THICKNESS SKIN GRAFTS. THE PADGETT DERMATOME WAS BEING USED TO HARVEST DONOR SKIN. THE PHYSICIAN NOTICED THE SKIN DEPTH TO BE DEEPER THAN THE SET LEVEL OF 0.10, SO SHE STOPPED. SHE AND OTHER STAFF MEMBERS ALSO NOTICED A BLACK SUBSTANCE ON THE PATIENT'S THIGHS WHERE THEY HAD BEEN ATTEMPTING TO HARVEST SKIN. PRIOR TO BEGINNING THIS PROCEDURE THE PADGETT DERMATOME HAD BEEN NOTED TO BE FREE FROM ANY OBSERVABLE PARTICULATE. IT ALSO PASSED THE INDICATOR TEST PRIOR TO BEING USED. AS A RESULT OF THE FIRST PADGETT DERMATOME'S MALFUNCTIONING, A SECOND ONE WAS USED. IT WAS PREPARED FOR USE AT THE DESIRED DEPTH OF 0.10. AGAIN THE PADGETT DERMATOME PRODUCED VARYING DEPTHS OF THE SKIN SHEET UPON COMPLETION OF A PASS.======================MANUFACTURER RESPONSE FOR INTEGRA PADGETT DERMATOME, PADGETT (PER SITE REPORTER)======================AN INTEGRA REPRESENTATIVE, WHO IS THE MANAGER OF MEDICAL COMPLAINTS DIVISION WILL BE A SENDING A PROFESSIONAL OUT TO DO A DEMONSTRATION AND FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PADGETT INTEGRA PADGETT DERMATOME GFD INTEGRA LIIFESCIENCES CORPORATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR NO OTHER THERAPIES| NONE IDENTIFIED.