inforMED
InjuryILH

THUMB CMC ABDUCTION ORTOHSIS

Received Oct 25, 2018 · Event occurred Oct 5, 2018

Report MW5080820 · MDR key 8008919

Device

Generic name

Splint, Hand, And Components

Model number

NC79499-P

Product problems

  • Patient-Device Incompatibility

Patient

64 YR

  • Itching Sensation
  • Peeling
  • Rash
  • Swelling
  • Burning Sensation
  • Itching Sensation
  • Peeling
  • Rash
  • Swelling
  • Burning Sensation

Narrative

Description of Event or Problem

ADVERSE REACTION TO THUMB CMC ABDUCTION ORTHOSIS PRESCRIBED FOR THUMB/WRIST SPRAIN (WAS ORIGINALLY AS BROKEN) MADE FROM NEOPRENE WITH ANTI-MICROBIAL TREATED TERRYCLOTH LINING. I DEVELOPED A BURN-LIKE REACTION ON WRIST THAT ITCHED, BLISTERED, PEELED AND ALSO DEVELOPED A RASH. THE BURN/PEELING WAS UNDER THE SPLINT ON THE WRIST AND THE RASH BEGAN AT THE BOTTOM OF MY THUMB AND EXTENDED ACROSS THE BACK OF MY HAND. ALMOST FOUR WEEKS LATER (REMOVING IT AFTER TWO WEEKS), I STILL HAVE THE RASH. MADE IN (B)(6), MFG BY NORTH COAST MEDICAL, INC. THANK YOU.