BEUDAMED
    FDA Adverse Event Other Summary report: N

    SCD EXPRESS SLEEVE K/L MEDIUM

    MDR report key: 2860286 · Received November 27, 2012

    Report

    Report Number
    1017072-2012-00011
    Event Type
    Other
    Date Received
    November 27, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 12, 2012
    Manufacturer
    COVIDIEN
    Product Code
    JOW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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)(4) 2012 THAT A CUSTOMER HAD AN ISSUE WITH A SCD SLEEVE. THE CUSTOMER STATES THE SLEEVE WAS USED ON A PT DURING A 4 HOUR C-SECTION PROCEDURE. THE SLEEVE WAS PLACED ON THE PT TIGHTLY WITHOUT INTERSPACE. THE PT WAS IN THE LITHOTOMY POSITION AND A LEVITATOR WAS USED DURING THIS PROCEDURE. AFTER 24 HOURS OF USE, COMPARTMENT SYNDROME AT LOWER FEMORAL ON RIGHT SIDE WAS APPARENT. IT WAS ASSUMED TO BE CAUSED BY ANESTHESIA; HOWEVER, THE PT'S CONDITION HAS NOT RECOVERED AND NOW IS ON REHABILITATION. NO HEMATOMA WAS CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCD EXPRESS SLEEVE K/L MEDIUM SCD SLEEVE JOW COVIDIEN 9528 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention