BEUDAMED
    FDA Adverse Event Other Summary report: N

    SCD COMFORT THIGH LENGTH MED

    MDR report key: 2913621 · Received January 8, 2013

    Report

    Report Number
    1017072-2013-00001
    Event Type
    Other
    Date Received
    January 8, 2013
    Date of Event
    December 7, 2012
    Report Date
    December 21, 2012
    Manufacturer
    COVIDIEN
    Product Code
    JOW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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)(6) 2012 THAT A CUSTOMER HAD AN ISSUE WITH AN SCD SLEEVE. THE CUSTOMER STATES AN SCD SLEEVE LEAKED WHICH CAUSED THE PUMP TO ALARM. THE COMPRESSION SLEEVE COULD NOT BE REPLACED BECAUSE THE FACILITY WAS OUT OF STOCK OVER THE WEEKEND. AS A RESULT, THE PT WAS GIVEN A HIGHER DOSE OF HEPARIN UNTIL A NEW SLEEVE ARRIVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10168 SCD COMFORT THIGH LENGTH MED SCD SLEEVE JOW COVIDIEN 74012 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other