BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODEL B 110 V ELECTRO DERMATOME COMPLETE KIT

    MDR report key: 5268811 · Received December 4, 2015

    Report

    Report Number
    3004608878-2015-00301
    Event Type
    Injury
    Date Received
    December 4, 2015
    Report Date
    July 8, 2015
    Manufacturer
    INTEGRA LIFESCIENCES CORP (INTEGRA-OHIO)
    Product Code
    GFD
    PMA / PMN Number
    EXEMPT
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 22DEC2015. THE INVESTIGATION INCLUDED: METHODS: REVIEW OF DEVICE HISTORY RECORDS. REVIEW OF COMPLAINT HISTORY. RESULTS: DEVICE HISTORY RECORD REVIEWED FOR 2-11594 MANUFACTURED ON 09/10/2013 SHOW NO ABNORMALITIES RELATED TO REPORTED INCIDENT FOUND. THIS DEVICE PASSED ALL REQUIRED INSPECTION POINTS WITH NO ASSOCIATED MRR¿S, VARIANCES OR REWORK. NO MANUFACTURING OR DESIGN RELATED TREND HAS BEEN IDENTIFIED. CONCLUSION: IN SUMMARY - THE DEVICE WAS NOT RELEASED FOR EVALUATION THEREFORE THE ROOT CAUSE TO THE END USERS EXPERIENCE COULD NOT BE DETERMINED. THIS COMPLAINT WILL BE REOPENED SHOULD WE RECEIVE PRODUCT. PLEASE NOTE, PER THE IFU: "THE ACTUAL THICKNESS OF THE HARVESTED TISSUE IS HIGHLY DEPENDENT UPON THE OPERATOR TECHNIQUE AND THE CONDITION OF THE TISSUE BEING HARVESTED." IF END-USER CONTINUES TO EXPERIENCE ISSUES WITH GRAFT QUALITY, FURTHER TRAINING IS RECOMMENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT SUFFERED AN INJURY DUE TO A DEVICE ISSUE. THE PATIENT WAS UNDERGOING A PLASTIC SURGERY PROCEDURE ON HIS LEG. "WE HAVE RECENTLY INSTALLED AN INTEGRA PADGETT ELECTRO-DERMATOME MODEL: B SERIAL NUMBER: (B)(4). WE ARE FACING PROBLEM IN THE UNIT AS WHEN WE ADJUST IT TO A SPECIFIC SIZE FOR PICKING A GRAFT, IT GOES DEEPER IN THE SKIN. PLEASE ADVISE WHAT TO DO." IT WAS LATER REPORTED THE DEVICE CUTS DEEPER. THE PATIENT WAS TREATED. HE HAS RECOVERED AND WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796545 MODEL B 110 V ELECTRO DERMATOME COMPLETE KIT SKIN GRAFT PRODUCTS GFD INTEGRA LIFESCIENCES CORP (INTEGRA-OHIO) MODEL B

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention