BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PICO SINGLE USE NPWT 15 X 20CM

    MDR report key: 5024822 · Received August 24, 2015

    Report

    Report Number
    8043484-2015-00252
    Event Type
    Injury
    Date Received
    August 24, 2015
    Date of Event
    January 13, 2015
    Report Date
    July 24, 2015
    Manufacturer
    SMITH & NEPHEW MEDICAL LTD.
    Product Code
    OMP
    PMA / PMN Number
    K112127
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SMITH & NEPHEW MEDICAL LTD. IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THE REPORT IS BASED UPON INFORMATION OBTAINED BY SMITH & NEPHEW, MEDICAL LTD.

    Description of Event or Problem · 1

    INFECTION AFTER RESECTION OF SKIN ABSCESS ON LEG, PICO HAD BEEN USED FOR 23 DAYS FOR THE PATIENT. PICO USE WAS DISCONTINUED DUE TO INFECTION. PATIENT TREATED FOR 3 WEEKS WITH IODINE SUGAR, PATIENT RECOVERED FROM THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557543 PICO SINGLE USE NPWT 15 X 20CM POWERED SUCTION PUMP OMP SMITH & NEPHEW MEDICAL LTD. 66800955

    Patients

    Seq Age Sex Outcome Treatment
    1