BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENASYS GO RENTAL DEVICE

    MDR report key: 4190268 · Received October 21, 2014

    Report

    Report Number
    3006760724-2014-00426
    Event Type
    Injury
    Date Received
    October 21, 2014
    Date of Event
    October 4, 2014
    Report Date
    March 27, 2015
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    OMP
    PMA / PMN Number
    K083375
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    PATIENT DEVELOPED AN UNDERLYING BLEED WHILE USING NPWT.

    Description of Event or Problem · 1

    PATIENT DEVELOPED AN UNDERLYING BLEED WHILE USING NPWT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668229 RENASYS GO RENTAL DEVICE RENASYS GO RENTAL DEVICE OMP SMITH & NEPHEW, INC. 66800164R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other