BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CWS 400 CLOSED WOUND SUCTION KIT

    MDR report key: 2910058 · Received November 28, 2012

    Report

    Report Number
    1018233-2012-01883
    Event Type
    Malfunction
    Date Received
    November 28, 2012
    Date of Event
    October 22, 2012
    Report Date
    October 30, 2012
    Manufacturer
    PRODUCTOS PARA EL CUIDADO DE LA SALUD
    Product Code
    GCY
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS FORTHCOMING. ONCE THE SAMPLE IS RECEIVED AND EVALUATED A MDR SUPPLEMENTAL WILL BE FILED.

    Description of Event or Problem · 1

    USER MEDWATCH#(B)(4) RECEIVED. THE PT UNDERWENT A TOTAL RIGHT KNEE ARTHROPLASTY ON (B)(6) 2012 WITH INSERTION OF HEMOVAC DRAIN. ON THE FOLLOWING DAY (B)(6) 2012, DURING AN ATTEMPT TO REMOVE THE DRAIN, THE RN EXPERIENCED DIFFICULTY AND STOPPED REMOVAL. DURING ROUNDS, THE PHYSICIAN'S ASSISTANT ATTEMPTED REMOVAL OF THE DRAIN AND EXPERIENCED DIFFICULTY AND HAD CONCERN THA A PORTION OF THE DRAIN MIGHT BE RETAINED INSIDE THE PT'S RIGHT KNEE. AN X-RAY OF THE RIGHT KNEE SHOWED "SEGMENT OF TUBING IN SUPRAPATELLAR SPACE". ON (B)(6) 2012 THE PT UNDERWENT AN ADDITIONAL SURGICAL PROCEDURE TO REMOVE THE REMAINING FRAGMENT OF THE DRAIN WHICH WAS IDENTIFIED AS APPROXIMATELY 6CM. ON (B)(6) 2012 THE PT'S POST-OP CONDITION WAS STABLE AND THERE WAS NO FURTHER IMPACT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CWS 400 CLOSED WOUND SUCTION KIT GCY PRODUCTOS PARA EL CUIDADO DE LA SALUD NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention