BEUDAMED
    FDA Adverse Event Summary report: N

    B-COOL

    MDR report key: 2842778 · Received November 16, 2012

    Report

    Report Number
    2842778
    Date Received
    November 16, 2012
    Date of Event
    April 20, 2011
    Report Date
    November 14, 2012
    Manufacturer
    BIRD & CRONIN
    Product Code
    FMQ
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE TRAUMA PATIENT SUSTAINED COMPLEX LOWER EXTREMITY FRACTURES REQUIRING FASCIOTOMIES BECAUSE OF COMPARTMENTAL SYNDROME. THE PATIENT HAD FOUR SEPARATE SURGERIES ON HIS LEGS IN THE FIRST TEN DAYS OF ADMISSION. THE PATIENT'S LEGS HAD USE OF EXTERNAL FIXATES, MULTIPLE WOUND VACS, DRESSINGS, IMMOBILIZERS AND FOOT PUMPS. VISIBILITY OF THE SKIN WAS LIMITED. ON THE 10TH DAY AFTER ADMISSION NEW BREAKS IN SKIN INTEGRITY WERE NOTED AFTER LOWER EXTREMITY DRESSING CHANGES AND TWO STAGE II PRESSURE ULCERS ON THE PATIENT'S RIGHT POSTERIOR LEG WERE ATTRIBUTED TO THE IMMOBILIZER. THE IMMOBILIZERS WERE REMOVED WHEN PATIENT WAS IN BED. THE WOUNDS DID RESOLVE/HEAL PRIOR TO DISCHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 B-COOL BRACE, EXTERNAL FMQ BIRD & CRONIN * *
    2 B-COOL BRACE, EXTERNAL FMQ BIRD & CRONIN * *

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR