BEUDAMED
    FDA Adverse Event Death Summary report: N

    SCD EXPRESS SLEEVE K/L MEDIUM

    MDR report key: 1901333 · Received November 3, 2010

    Report

    Report Number
    1017072-2010-00028
    Event Type
    Death
    Date Received
    November 3, 2010
    Date of Event
    October 12, 2010
    Report Date
    October 29, 2010
    Manufacturer
    COVIDIEN
    Product Code
    JOW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(6) 2010. 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) 2010 THAT A CUSTOMER HAD AN ISSUE WITH A PAIR OF SCD EXPRESS SLEEVES. THE CUSTOMER REPORTS THAT A PT HAD A STROKE AND PASSED AWAY. CUSTOMER DID NOT FEEL THAT THE SCD SYSTEM WAS RESPONSIBLE BUT WOULD LIKE ALL PIECES INVESTIGATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCD EXPRESS SLEEVE K/L MEDIUM SCD EXPRESS SLEEVES JOW COVIDIEN 9529 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death