BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CWS 400 CLOSED WOUND SUCTION KIT

    MDR report key: 2980565 · Received February 21, 2013

    Report

    Report Number
    1018233-2013-00501
    Event Type
    Injury
    Date Received
    February 21, 2013
    Report Date
    January 24, 2013
    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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT RETURNED. THE LOT NUMBER IS UNKNOWN; THEREFORE THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. INSTRUCTIONS FOR USE STATE THE FOLLOWING PRECAUTIONS TO AVOID THE POSSIBILITY OF DRAIN DAMAGE OR BREAKAGE: ADDITIONAL PERFORATIONS SHOULD NOT BE MADE IN THE DRAIN. AVOID SUTURING THROUGH DRAIN. DRAIN SHOULD LIE FLAT AND IN LINE WITH THE SKIN EXIT AREAS. PARTICULAR CARE SHOULD BE TAKEN TO AVOID ANY OBSTACLES TO THE DRAIN EXIT PATH. DRAIN SHOULD BE CHECKED FOR FREE MOTION DURING CLOSURE TO MINIMIZE THE POSSIBILITY OF BREAKAGE. DRAIN REMOVAL SHOULD BE DONE GENTLY BY HAND. DRAIN SHOULD NOT BE HANDLED WITH POINTED, TOOTHED, OR SHARP INSTRUMENTS WHICH COULD CAUSE CUTS OR NICKS AND LEAD TO SUBSEQUENT STRUCTURAL FAILURE OF THE DRAIN. SURGICAL REMOVAL MAY BE NECESSARY IF DRAIN IS DIFFICULT TO REMOVE OR BREAKS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DRAIN BROKE OFF IN THE PT'S KNEE WHEN THE DRAIN WAS PULLED FROM THE PT'S WOUND POST OPERATIVELY. THE PT WAS RETURNED TO SURGERY FOR REMOVAL OF THE RETAINED PORTION OF THE DRAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75135 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