BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PICO SINGLE USE NPWT 10 X 20CM

    MDR report key: 4882503 · Received July 1, 2015

    Report

    Report Number
    8043484-2015-00055
    Event Type
    Injury
    Date Received
    July 1, 2015
    Date of Event
    November 24, 2014
    Report Date
    November 24, 2014
    Manufacturer
    SMITH & NEPHEW MEDICAL LTD.
    Product Code
    OMP
    PMA / PMN Number
    K112127
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PICO HAD POSSIBLY CAUSED MACERATION TO A TIP OF A PATIENTS BIG TOE (LEFT FOOT), WHICH WAS ON THE TOE FOR A CAVITY FURTHER DOWN ON THE ANTERIOR ASPECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424519 PICO SINGLE USE NPWT 10 X 20CM NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP OMP SMITH & NEPHEW MEDICAL LTD. 66800951

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention