BEUDAMED
    FDA Adverse Event Other Summary report: N

    SCD EXPRESS SLEEVE K/L MEDIUM

    MDR report key: 3076628 · Received April 22, 2013

    Report

    Report Number
    3006451981-2013-00123
    Event Type
    Other
    Date Received
    April 22, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 17, 2013
    Manufacturer
    COVIDIEN MEDICAL PRODUCTS SHANGHAI MANUFACTURING. LLC
    Product Code
    JOW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2013. 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 SCD SLEEVE. THE CUSTOMER STATES POST USE, THE PATIENT COMPLAINED OF PAIN, AND COMPARTMENT SYNDROME WAS FOUND. AN SCD EXPRESS SLEEVE WAS USED ON THE PATIENT DURING GYNECOLOGICAL SURGICAL PROCEDURE ALONG WITH THE USE OF LEVITATOR (LITHOTOMY POSITION) FOR ABOUT 6-7 HOURS. THE PATIENT HAD A RELAXATION INCISION FOR THE COMPARTMENT SYNDROME. THE PATIENT HAS RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172141 SCD EXPRESS SLEEVE K/L MEDIUM SCD SLEEVE JOW COVIDIEN MEDICAL PRODUCTS SHANGHAI MANUFACTURING. LLC 9529 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention