BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYONICS 25

    MDR report key: 1874273 · Received October 12, 2010

    Report

    Report Number
    1874273
    Event Type
    Injury
    Date Received
    October 12, 2010
    Date of Event
    September 28, 2010
    Report Date
    October 11, 2010
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HRX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A (B)(6) FEMALE ADMITTED WITH DIAGNOSIS OF RIGHT SHOULDER ROTATOR CUFF TEAR. SHE UNDERWENT AN ARTHROSCOPIC ROTATOR CUFF REPAIR OF HER RIGHT SHOULDER. INTRA-OP PER SURGEON NOTED PUMP MALFUNCTION DURING OF THE PROCEDURE AND THE PT HAD SOME MORE THAN NORMAL SWELLING OF THE ANTERIOR ARM. PER SURGEON, PUMP SWITCHED AND SWELLING NOTED TO BE RESOLVING BY THE END OF THE PROCEDURE. OF NOTE PER STAFF, UNIT DID NOT SEEM TO DETECT THE INSTRUMENT THAT WAS ATTACHED. WATER/IRRIGATION SPILLED ON THE FLOOR. MFR REP, (B)(4) NOTIFIED, (B)(4). ALSO SPOKE TO (B)(4) AT SMITH & NEPHEW, VERY COOPERATIVE IN SETTING UP S&H FOR UNIT TO BE EVALUATED ONCE CLEARANCE OBTAINED AT OUR HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DYONICS 25 ARTHROSCOPIC IRRIGATION PUMP HRX SMITH & NEPHEW, INC. 7211010

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention