MIAMI J SELECT
Received Oct 30, 2025 · Event occurred Aug 30, 2025
Report 3003764610-2025-00009 · MDR key 23425110
Device
Product problems
- Malposition of Device
- Insufficient Device Problem Information
- Malposition of Device
- Insufficient Device Problem Information
Patient
NA · Unknown
- Skin Erosion
- Skin Erosion
Narrative
Description of Event or Problem
A PATIENT WHO WAS WEARING A CERVICAL COLLAR DEVELOPED AN UNSTAGEABLE HOSPITAL ACQUIRED PRESSURE INJURY ON THE RIGHT CLAVICLE DUE TO THE HARD PLASTIC EDGE OF THE COLLAR PRESSING INTO THE PATIENT'S SKIN.
Description of Event or Problem
A PATIENT WHO WAS WEARING A CERVICAL COLLAR DEVELOPED AN UNSTAGEABLE HOSPITAL ACQUIRED PRESSURE INJURY ON THE RIGHT CLAVICLE DUE TO THE HARD PLASTIC EDGE OF THE COLLAR PRESSING INTO THE PATIENT'S SKIN.
Additional Manufacturer Narrative
PRESSURE INJURIES CANNOT BE FULLY PREVENTED WITH SUPINE PATIENTS AND THEREFORE APPROPRIATE SKIN CARE PROTOCOL IS CRUCIAL. PRESSURE INJURY DEVELOP WITH TIME AND INFORMATION SUGGEST THAT THE PRESSURE INJURY HAS BEEN NOTED AND REACTED TO AS THEY REPORTED TO HAVE USED FIVE-LAYER DRESSINGS AT THE WOUND AREA. THE PROBABILITY OF ISSUE CAUSING OR CONTRIBUTING TO A SERIOUS INJURY IF ISSUE WERE TO RECUR IS CONSIDERED NEGLIGIBLE BASED ON PMS DATA. PRODUCT WILL CONTINUE TO BE MONITORED.