BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNKNOWN SCD

    MDR report key: 1914104 · Received November 24, 2010

    Report

    Report Number
    1017072-2010-00031
    Event Type
    Other
    Date Received
    November 24, 2010
    Date of Event
    December 7, 2010
    Report Date
    November 15, 2010
    Manufacturer
    COVIDIEN
    Product Code
    JOW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    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) 2010 THAT A CUSTOMER HAS AN ISSUE WITH AN SCD SLEEVE. THE CUSTOMER REPORTS THAT THE PT HAD LUMBAR DECOMPRESSION AND LUMBAR FUSION ON (B)(6) 2009. THE PT SUSTAINED BILATERAL HEEL PRESSURE SORES STAGE 2. RIGHT 10.5 CM X 7 CM. LEFT 8.5 CM X 9.5 CM. PHYSICIAN OPENED BLISTERS AND TREATED WITH ADAPTIC. PT EVENTUALLY NEEDED PLASTIC SURGERY TO CLOSE HEEL WOUNDS. AT 6 MONTHS, THE RIGHT HEEL WAS HEALED, LEFT HEEL STILL OPEN. AT 9 MONTHS, NO MENTION OF EITHER HEEL WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN SCD SCD SLEEVE JOW COVIDIEN UNK SCD UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other