BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JRNY BCS II

    MDR report key: 3921568 · Received July 9, 2014

    Report

    Report Number
    1020279-2014-00395
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    May 28, 2014
    Report Date
    July 8, 2014
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED AND TREATED FOR INFECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED AND TREATED FOR MASSIVE LYMPHEDEMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402160 JRNY BCS II JRNY BCS II JWH SMITH & NEPHEW, INC. 13FM09145

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 74024835/ 13JM16273| 74022125/ 13LM06235| 74022225/ 13KM21361