BEUDAMED
    FDA Adverse Event Other Summary report: N

    KNEE LENGTH MED/REG TED

    MDR report key: 3410931 · Received October 4, 2013

    Report

    Report Number
    3009211636-2013-00003
    Event Type
    Other
    Date Received
    October 4, 2013
    Date of Event
    September 9, 2013
    Report Date
    September 9, 2013
    Manufacturer
    COVIDIEN MANUFACTURING SOLULFONS SA
    Product Code
    DWL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    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) 2013 THAT A CUSTOMER HAD AN ISSUE WITH A COMPRESSION STOCKING. THE CUSTOMER STATES AN ELDERLY PATIENT HAD DEVELOPED STAGE THREE PRESSURE ULCERS. THE CHARGE NURSE MANAGER INDICATES THE TED STOCKING AS THE CAUSE OF THE STAGE 3 PRESSURE AREAS/INJURIES (CLAIMING CORRECT MEASUREMENTS WERE COMPLETED) DUE TO STOCKINGS RESTING BEHIND THE KNEE. CORRECTIVE ACTION TAKEN RELEVANT TO THE CARE OF THE PATIENT: TED STOCKINGS WERE PULLED DOWN FROM PRESSURE AREA. THE PATIENT DIED FROM OTHER CO-MORBIDITIES. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502725 KNEE LENGTH MED/REG TED COMPRESSION STOCKING DWL COVIDIEN MANUFACTURING SOLULFONS SA 7115 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other