BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NPWT PICO

    MDR report key: 4877322 · Received June 30, 2015

    Report

    Report Number
    8043484-2015-00034
    Event Type
    Injury
    Date Received
    June 30, 2015
    Date of Event
    April 29, 2015
    Report Date
    April 29, 2015
    Manufacturer
    SMITH & NEPHEW MEDICAL LTD.
    Product Code
    OMP
    PMA / PMN Number
    K111170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT IS EXISTING TWICE IN OUR RECORD AND WAS REPORTED TO THE FDA TWICE (SEE ALSO MDR REFERENCE NUMBER: 8043484-2015-00009). WE ARE SUBMITTING A CORRECTION REPORT TO THE FDA AS THIS COMPLAINT WILL BE CLOSED AS A DUPLICATE COMPLAINT AND WILL BE THEREFORE NO LONGER INVESTIGATED. THE INVESTIGATION IS CONDUCTED UNDER MDR REFERENCE NUMBER: 8043484-2015-00009.

    Description of Event or Problem · 1

    IT WAS BROUGHT TO OUR ATTENTION THAT PICO WAS PLACED ON A PATIENT UNDER A CAST BELOW THE KNEE , THE WOUND DEHISCED, BONE AND METAL IMPLANT WERE EXPOSED. THE PATIENTS' LIMB WAS LATER AMPUTATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423493 NPWT PICO UNKNOWN PICO OMP SMITH & NEPHEW MEDICAL LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention