BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIAMI J COLLAR

    MDR report key: 6016359 · Received October 11, 2016

    Report

    Report Number
    6016359
    Event Type
    Malfunction
    Date Received
    October 11, 2016
    Date of Event
    August 21, 2015
    Report Date
    September 29, 2016
    Manufacturer
    OSSUR AMERICAS
    Product Code
    IQK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AN ELDERLY FEMALE WAS BROUGHT THE EMERGENCY DEPARTMENT FOLLOWING A TRAUMATIC MOTOR VEHICLE ACCIDENT. SHE WAS IMMEDIATELY ASSESSED, INCLUDING PLACEMENT OF A MIAMI J COLLAR, AND EMERGENTLY TAKEN FOR ORTHOPEDIC SURGERY DUE TO SIGNIFICANT BLOOD LOSS FROM AN OPEN FRACTURE OF HER RIGHT LOWER EXTREMITY. FOLLOWING SURGERY, SHE WAS ALSO FOUND TO HAVE SUFFERED BILATERAL RIB FRACTURES AND THORACIC AND CERVICAL FRACTURES. NEUROSURGERY WAS CONSULTED AND SHE WAS FOUND TO HAVE AN UNSTABLE THORACIC SPINAL CORD INJURY. THE PATIENT WAS ON STRICT BED REST WITH LOG-ROLLING ONLY FOR SEVERAL DAYS UNTIL SHE WAS ORDERED TO LIE FLAT WITH NO LOG ROLLING. SHE WAS FITTED FOR A NEW MIAMI J COLLAR. A WEEK LATER, SHE UNDERWENT A SPINAL FUSION. A FEW DAYS LATER, THE PATIENT'S ACTIVITY LEVEL WAS ORDERED FOR PROGRESSIVE AMBULATION AND THE PATIENT WAS TRANSFERRED TO MED/SURG. SHE REQUIRED 2-3 STAFF TO ASSIST FOR TURNING. AFTER THE TRANSFER, HER O2 SATURATIONS BEGAN TO DECREASE AND SHE WAS REQUIRING INCREASED SUCTIONING AND WAS TRANSFERRED BACK TO THE ICU. TWO MONTHS AFTER THE MOTOR VEHICLE ACCIDENT, AN UNSTAGEABLE PRESSURE ULCER WAS NOTED ON THE PATIENT'S RIGHT OCCIPITAL AREA AT THE EDGE OF WHERE THE MIAMI J COLLAR RESTS. A FEW DAYS LATER A SECOND UNSTAGEABLE PRESSURE ULCER WAS NOTED ON THE PATIENT'S LEFT OCCIPITAL AREA ALSO BELIEVED TO BE RELATED TO THE MIAMI J COLLAR. A WEEK LATER, SHE WAS TRANSFERRED BACK TO (B)(6) RESPIRATORY AND THE MIAMI J COLLAR WAS REMOVED AND THE PATIENT WAS DISCHARGED TO ACUTE REHABILITATION. WOUND OSTOMY SAW THE PATIENT. THE LEFT POSTERIOR HEAD PRESSURE ULCER WAS STAGE III. THE RIGHT AREAS WERE STILL UNSTAGEABLE. FOUR MONTHS AFTER THE ACCIDENT, THE PATIENT WAS DISCHARGED HOME WITH HOME HEALTH SERVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669012 MIAMI J COLLAR ORTHOSIS, CERVICAL IQK OSSUR AMERICAS MJ400

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other CARDIAC DRUGS| NO