BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3856LF TED STKG NYL T/L LL

    MDR report key: 4190392 · Received October 21, 2014

    Report

    Report Number
    3009211636-2014-00122
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    June 22, 2013
    Report Date
    October 15, 2014
    Manufacturer
    COSTA RICA
    Product Code
    FQL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOT NUMBER ASSOCIATED WITH THIS COMPLAINT WAS NOT PROVIDED. WITHOUT THE LOT NUMBER, A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED. ALL DHRS ARE REVIEWED FOR ACCURACY PRIOR TO PRODUCT RELEASE. THE COMPLAINT SAMPLE WAS NOT RETURNED TO THE MANUFACTURING SITE FOR REVIEW. WITHOUT THE SAMPLE, IT IS NOT POSSIBLE TO DETERMINE A CONFIRMED ROOT CAUSE OF THIS ISSUE. SHOULD THE SAMPLE BE RETURNED IN THE FUTURE, THIS COMPLAINT WILL BE RE-OPENED FOR FURTHER INVESTIGATION. COMPLAINT TRENDING INFORMATION IS BEING REVIEWED ON A MONTHLY BASIS AND IF A TREND IS OBSERVED, ACTIONS WILL BE TAKEN AS NECESSARY. IT MUST BE NOTED THAT IN-PROCESS CONTROLS (SUCH AS PERSONNEL TRAINING, INCOMING QUALITY ACCEPTANCE TESTING FOR RAW MATERIAL, 100% IN PROCESS VISUAL INSPECTION AND VISUAL ACCEPTANCE SAMPLING) ARE IN PLACE TO PREVENT NONCONFORMING PRODUCT FROM LEAVING THE MANUFACTURING OPERATIONS. THIS INFORMATION WILL BE UTILIZED FOR TRACKING AND TRENDING PURPOSES TO DETERMINE THE NEED FOR CORRECTIVE ACTION.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A TED STOCKING. THE CUSTOMER STATES A PATIENT WAS HOSPITALIZED IN A CARE UNIT FOR A SURGERY ON (B)(6) 2013. THE PATIENT WAS WEARING ANTI-EMBOLIC STOCKINGS IN COMBINATION WITH A COMPRESSION SEQUENTIAL DEVICE AS RECOMMENDED IN PREVENTION OF THROMBOPHLEBITIS. THE DAY AFTER THE SURGERY, THE PATIENT PRESENTED THE FOLLOWING SYMPTOMS: LOSS OF SENSITIVITY TO THE ANKLE, LEFT FOOTDROP DUE TO THE COMPRESSION OF THE COMMON PERONEAL NERVE AND HEMATOMAS IN THE TWO LEGS WERE OBSERVED SUBSEQUENTLY. THE SALES REP CONFIRMED SHE WAS NEVER NOTIFIED OF THIS COMPLAINT AND SHE IS TRYING TO OBTAIN ADDITIONAL INFORMATION WITH THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667356 3856LF TED STKG NYL T/L LL TED STOCKING FQL COSTA RICA 3856LF

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization