BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PICO SINGLE USE NPWT 10 X 30CM

    MDR report key: 5404583 · Received February 2, 2016

    Report

    Report Number
    8043484-2016-00008
    Event Type
    Injury
    Date Received
    February 2, 2016
    Date of Event
    January 20, 2016
    Report Date
    January 20, 2016
    Manufacturer
    SMITH & NEPHEW MEDICAL LTD.
    Product Code
    OMP
    PMA / PMN Number
    K112127
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    PATIENT USED PICO SINCE (B)(6), 2016. ON THE (B)(6), DRESSING WAS CHANGED.PICO PUMP STOPPED WORKING SINCE (B)(6), BUT THE PATIENT LEFT THE DRESSING IN PLACE UNTIL (B)(6). ON THE FOLLOW-UP VISIT IT WAS OBSERVED THAT THE WOUND HAD RE-OPENED AND DETERIORATED GREATLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63210 PICO SINGLE USE NPWT 10 X 30CM POWERED SUCTION PUMP OMP SMITH & NEPHEW MEDICAL LTD. 66800952

    Patients

    Seq Age Sex Outcome Treatment
    1