MalfunctionIME
MEDICHOICE INSTANT WARM COMPRESS
Received Mar 13, 2019 · Event occurred Feb 1, 2019
Report 8416164 · MDR key 8416164
Device
Generic name
Pack, Hot Or Cold, Reusable
Manufacturer
Owens & Minor Distribution, Inc.Lot number
24818-2
Product problems
- Temperature Problem
Patient
Not reported
- No Information
- No Information
Narrative
Description of Event or Problem
INCONSISTENTLY PERFORMING- SOME TOO HOT WHILE OTHERS ARE TOO COLD. PACKAGING STATES UP TO 115 DEGREES. FEELS MUCH WARMER AT TIMES THAN THIS. OPENED BOX ON UNIT AND HAS NO SLEEVES EVEN THOUGH BOX STATES "WITH SLEEVE." OTHER BOXES HAVE SLEEVES, SIGNAGE BEING PLACED TO USE WITH SLEEVE OR IN PILLOWCASE.