MalfunctionIQK
MIAMI J SELECT COLLAR SET
Received Jul 16, 2025 · Event occurred Mar 25, 2025
Report 22519411 · MDR key 22519411
Device
Generic name
Orthosis, Cervical
Manufacturer
Ossur AmericasModel number
MJSR-101Catalog number
MJSR-101
Lot number
MX250217
Product problems
- Inadequacy of Device Shape and/or Size
- Patient Device Interaction Problem
Patient
55 YR · Male
- Ulcer
- Ulcer
Narrative
Description of Event or Problem
PATIENT WEARING THE MIAMI J COLLAR AND DEVELOPED AN UNSTAGEABLE, RIGHT CLAVICLE PRESSURE INJURY. IT WAS NOTICED THAT THE PADDING INSIDE THE COLLAR DID NOT COME DOWN TO THE DISTAL END OF THE COLLAR, SO THERE WAS ONLY PLASTIC ON THE PATIENT'S SKIN.