BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WOUND DRAIN

    MDR report key: 2913415 · Received January 9, 2013

    Report

    Report Number
    1018233-2013-00042
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Report Date
    December 14, 2012
    Manufacturer
    PRODUCTOS PARA EL CUIDADO DE LA SALUD
    Product Code
    GCY
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT RETURNED. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE, WHICH ACCOMPANIES ALL DEVICES, CURRENTLY ADDRESSES THE POTENTIAL RISKS ASSOCIATED WITH SURGICALLY IMPLANTED MATERIALS. THE INSTRUCTIONS FOR USE STATES IN THE PRECAUTIONS: TO AVOID THE POSSIBILITY OF DRAIN DAMAGE OR BREAKAGE: ADD'L PERFORATIONS SHOULD NOT BE MADE IN THE DRAINS; AVOID SUTURING THROUGH THE DRAINS; DRAINS SHOULD LIE FLAT AND IN LINE WITH THE SKIT EXIT AREAS; PARTICULAR CARE SHOULD BE TAKEN TO AVOID ANY OBSTACLES TO THE DRAIN EXIT PATH; DRAINS SHOULD BE CHECKED DURING CLOSURE FOR FREE MOTION TO AVOID POSSIBILITY OF BREAKAGE; DRAIN REMOVAL SHOULD BE DONE GENTLY BY HAND. THEY 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE REMOVING THE DRAIN FORM THE PT FOLLOWING A SURGICAL PROCEDURE ON THE PT'S ANKLE, A PORTION OF THE DRAIN BROKE AND REMAINS IN THE PT. ADD'L INFO HAS BEEN REQUESTED, BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12844 WOUND DRAIN WOUND DRAIN GCY PRODUCTOS PARA EL CUIDADO DE LA SALUD NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1