InjuryILH
COMFORTPRENE, BLUE 1/8 IN
Received Sep 29, 2016 · Event occurred Jan 1, 2016
Report 2939821-2016-00001 · MDR key 5989091
Device
Generic name
Splint Component
Manufacturer
North Coast Medical, Inc.Model number
NC68002Catalog number
NC68002
Lot number
N/A
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
3 YR
- Local Reaction
- Local Reaction
Narrative
Additional Manufacturer Narrative
THIS PRODUCT IS MADE OF LATEX-FREE NEOPRENE.
Description of Event or Problem
PER CUSTOMER: "WE AT (B)(6) HAVE STARTED ORDERING YOUR COMFORTPRENE AS A REPLACEMENT PRODUCT FOR THE NEOPRENE WE USED TO ORDER THROUGH PATTERSON MEDICAL THAT WAS DISCONTINUED. WE MADE A HAND SPLINT FOR A YOUNG CHILD, WHO HAD A REACTION TO THE MATERIAL AFTER THE FIRST WEAR. IT GOT PROGRESSIVELY WORSE OVER TIME, AFTER THE SPLINT WAS REMOVED. THE CHILD WAS TAKEN TO THE GP WHO SAID THAT IT WAS A LATEX ALLERGY AND REQUIRED MEDICATION TO TRY TO CLEAR IT UP."