MalfunctionIME
MEDICHOICE INSTANT WARM COMPRESS
Received May 7, 2019 · Event occurred Feb 20, 2019
Report 8586078 · MDR key 8586078
Device
Generic name
Pack, Hot Or Cold, Reuseable
Manufacturer
Owens & Minor Distribution, IncProduct problems
- Use of Device Problem
Patient
Not reported
- Erythema
- Discomfort
- Erythema
- Discomfort
Narrative
Description of Event or Problem
POTENTIAL RISK TO PATIENTS USING MEDICHOICE INSTANT WARM COMPRESS. THE COMPRESS, EVEN WHEN USED AS DIRECTED (I.E.-IN THE PROTECTIVE SLEEVE PROVIDED BY THE MANUFACTURER), MAY CAUSE REDNESS AND DISCOMFORT WHEN APPLIED TO AFFECTED AREAS.