BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PADGETT ELECTRO-DERMATOME MODEL B 110 V

    MDR report key: 948808 · Received November 16, 2007

    Report

    Report Number
    3003418325-2007-00022
    Event Type
    Malfunction
    Date Received
    November 16, 2007
    Report Date
    November 16, 2007
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    GFD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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

    IT WAS REPORTED THAT THE DEVICE IS SHREDDING SKIN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR