BEUDAMED
    FDA Adverse Event Summary report: N

    PICO SINGLE USE NPWT 15 X 15CM

    MDR report key: 4930879 · Received July 22, 2015

    Report

    Report Number
    8043484-2015-00223
    Date Received
    July 22, 2015
    Date of Event
    June 18, 2015
    Report Date
    June 30, 2015
    Manufacturer
    SMITH & NEPHEW MEDICAL LTD.
    Product Code
    OMP
    PMA / PMN Number
    K112127
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDICAL DEVICE REPORT HAS BEEN SUBMITTED IN ERROR AND SMITH & NEPHEW HEREWITH WITHDRAWS THE REPORT WITH REFERENCE 8043484-2015-00223. THE REPORT IS WITHDRAWN DUE TO ERRONEOUS INFORMATION PROVIDED. THE EVENT HAS NOT LET TO SERIOUS INJURY PURSUANT TO THE PROVISIONS OF 21C.F.R., PART 803.

    Description of Event or Problem · 1

    PICO PUMP STOPPED WORKING ON THE SECOND DAY OF USE. SKIN MACERATION WAS REPORTED. A TWO DAY DELAY IN THERAPY WAS ALSO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476433 PICO SINGLE USE NPWT 15 X 15CM PICO SINGLE USE NPWT 15 X 15CM OMP SMITH & NEPHEW MEDICAL LTD. 66800954 1438

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention