OtherILH
COMFORT COOL THUMB CMC RESTRICTION SPLINT
Received Nov 9, 2011 · Event occurred Jul 15, 2011
Report 2939821-2011-00015 · MDR key 2331776
Device
Generic name
Thumb Cmc Restriction Splint
Manufacturer
North Coast Medical, Inc.Model number
NACatalog number
NC79560
Lot number
NA
Product problems
- Patient-Device Incompatibility
Patient
UNK
- Rash
Narrative
Description of Event or Problem
CUSTOMER WORE THIS SPLINT TWO TIMES. EACH TIME HE WORE THE SPLINT HE BROKE INTO A RASH ON THE TOP OF HIS HAND AND AT THE TOP PART OF HIS THUMB. HE COULD NOT REMEMBER THE EXACT DATE HE WORE THE SPLINT BUT ONCE HE DISCONTINUED THE USE, THE RASH WOULD DISAPPEAR IN TWO DAYS. THE SPLINT IS A LATEX FREE PRODUCT.
Remedial action
- Other