BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODEL B 110 V ELECTRO DERMATOME COMPLETE KIT

    MDR report key: 3940218 · Received June 19, 2014

    Report

    Report Number
    3004608878-2014-00094
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    June 1, 2014
    Report Date
    June 6, 2014
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    FZW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A PT INCIDENT WITH A DERMATOME MODEL B. ON (B)(6) 2014, ADD'L INFO WAS RECEIVED FROM THE NURSE RISK COORDINATOR. THE DEVICE WAS USED ON (B)(6) 2014 FOR GRAFT SURGERY. THE SURGEON STARTED TO TAKE A GRAFT FROM THE ANTERIOR RIGHT THIGH OF THE PT TO BE USED AS A GRAFT FOR A NON-HEALING WOUND ON THE RIGHT LOWER EXTREMITY. THE DERMATOME VIBRATED, STOPPING INTERMITTENTLY "CUTTING IN AND OUT". THE GRAFT WAS UNUSABLE. THE SURGERY WAS CANCELED AND THE PT WAS REFERRED TO A DIFFERENT SURGEON FOR FURTHER TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359470 MODEL B 110 V ELECTRO DERMATOME COMPLETE KIT SKIN GRAFT PRODUCTS FZW INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention