BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCD EXPRESS COMP SYSTEM JAPAN

    MDR report key: 2592162 · Received May 23, 2012

    Report

    Report Number
    1310379-2012-00018
    Event Type
    Injury
    Date Received
    May 23, 2012
    Date of Event
    April 25, 2012
    Report Date
    May 7, 2012
    Manufacturer
    COVIDIEN
    Product Code
    JOW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    05/23/2012. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    HOLD SBF. IT WAS REPORTED TO COVIDIEN ON (B)(6) 2012 THAT A CUSTOMER HAD AN ISSUE WITH A SCD PUMP. THE CUSTOMER STATES THE PT WAS PLACED ON THE OPERATING TABLE IN THE LITHOTOMY POSITION FOR BOWEL CANCER SURGERY WHICH TOOK 5 HOURS. AFTER THE PROCEDURE, THE PT DEVELOPED COMPARTMENT SYNDROME. THE PT IS DOING WELL AND WAS DISCHARGED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCD EXPRESS COMP SYSTEM JAPAN SCD PUMP JOW COVIDIEN 95257 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other