BEUDAMED
    FDA Adverse Event Other Summary report: N

    SCD EXPRESS SLEEVE K/L MEDIUM

    MDR report key: 2240595 · Received August 26, 2011

    Report

    Report Number
    1017072-2011-00006
    Event Type
    Other
    Date Received
    August 26, 2011
    Date of Event
    July 22, 2011
    Report Date
    July 29, 2011
    Manufacturer
    COVIDIEN
    Product Code
    JOW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2011. 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) 2011 THAT A CUSTOMER HAD AN ISSUE WITH AN SCD SLEEVE. THE CUSTOMER STATES THE PT HAD NUMBNESS TWO DAYS AFTER A SURGICAL PROCEDURE THAT LASTED 10 HOURS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other