BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PICO SINGLE USE NPWT 20 X 20CM

    MDR report key: 4881690 · Received July 1, 2015

    Report

    Report Number
    8043484-2015-00048
    Event Type
    Injury
    Date Received
    July 1, 2015
    Date of Event
    August 19, 2014
    Report Date
    September 15, 2014
    Manufacturer
    SMITH & NEPHEW MEDICAL LTD.
    Product Code
    OMP
    PMA / PMN Number
    K112127
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NURSE REPORTED THAT PATIENT ON PICO SINCE (B)(6) 2014. THE PATIENT DEVELOPED A RED MACERATED SKIN REACTION UNDER SECURING TAPES ON (B)(6) 2014. THE NURSE USED 'DUODERM' TO PROTECT DAMAGED SKIN WITH NO IMPROVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429117 PICO SINGLE USE NPWT 20 X 20CM NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP OMP SMITH & NEPHEW MEDICAL LTD. 66800957

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention