BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENASYS GO RENTAL

    MDR report key: 4781888 · Received May 19, 2015

    Report

    Report Number
    3006760724-2015-00052
    Event Type
    Injury
    Date Received
    May 19, 2015
    Date of Event
    March 9, 2015
    Report Date
    March 18, 2015
    Product Code
    OMP
    PMA / PMN Number
    K083375
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    LEAK THERAPY STARTED WEEK PRIOR, NO ISSUES FIRST TWO APPLICATIONS. A THIRD APPLICATION BY A DIFFERENT TEAM MEMBER. LEAK ALARM NOTED BY PATIENT AT THE END OF DAY TWO. NURSE WHO HAD APPLIED FIRST TWO DRESSINGS APPLIED THE 4TH APPLICATION AND NO FURTHER ISSUES. GOOD PROGRESS BETWEEN THE THIRD AND FOURTH APPLICATION. SLIGHT MACERATION AT THE PERI-WOUND AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326256 RENASYS GO RENTAL NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION OMP 66800612

    Patients

    Seq Age Sex Outcome Treatment
    1