FDA Adverse Event Injury Summary report: N

MIAMI J COLLAR

MDR report key: 6117749 · Received November 21, 2016

Report

Report Number
3008523132-2016-00005
Event Type
Injury
Date Received
November 21, 2016
Date of Event
August 21, 2015
Report Date
November 21, 2016
Manufacturer
OSSUR
Product Code
IQK
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
ME, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

AN ELDERLY FEMALE WAS BROUGHT TO THE EMERGENCY DEPARTMENT FOLLOWING A TRAUMATIC MOTOR VEHICLE ACCIDENT. SHE WAS IMMEDIATELY ASSESSED, INCLUDING PLACEMENT OF A MIAMI J COLLAR, AND TAKEN FOR ORTHOPEDIC SURGERY DUE TO SIGNIFICANT BLOOD LOSS FROM AN OPEN FRACTURE OF HER RIGHT LOWER EXTREMITY. 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 SPINAL FUSION. A FEW DAYS LATER, THE PATIENTS ACTIVITY LEVEL WAS ORDERED FOR PROGRESSIVE AMBULATION AND THE PATIENT WAS TRANSFERRED. SHE REQUIRED 2-3 STAFF TO ASSIST FOR TURNING. 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 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 3. THE RIGHT AREAS WERE STILL UNCHANGEABLE. FOUR MONTHS AFTER THE ACCIDENT, THE PATIENT WAS DISCHARGED HOME WITH HOME HEALTH SERVICES. THE SKIN UNDER THE MIAMI J COLLAR SHOULD BE ASSESSED EVERY SHIFT. BASED ON THE IFU THE PADS SHOULD BE CHANGED DAILY BUT THIS WAS NOT THE CURRENT PRACTICE IN CRITICAL CARE AND HAS SINCE BEEN IMPLEMENTED. TRANSCRIBED FROM MEDWATCH (B(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
769901 MIAMI J COLLAR ORTHOSIS, CERVICAL IQK OSSUR MJ-400

Patients

Seq Age Sex Outcome Treatment
1 65 YR Required Intervention