MalfunctionIME
THERMACARE
Received Aug 29, 2018 · Event occurred Aug 14, 2018
Report MW5079497 · MDR key 7832345
Device
Generic name
Pack, Hot Or Cold Reusable
Manufacturer
Pfizer Inc.Product problems
- Appropriate Device Problem Term/Code Not Available
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
AFTER PLACING THERMACARE WRAP ON THE JOINT AFTER PEELING OFF THE ADHESIVE BACKING PER THE INSTRUCTIONS. IT NEVER WARNED UP AT ALL. THE PRODUCT COMPLETELY MALFUNCTIONED AND DID NOT MEET ITS INTENDED USE. CLOSE TO TWO HOURS LATER, THERE WAS ABSOLUTELY NO INCREASE IN TEMPERATURE YET LABELING CLAIMS IT WORKS FOR UP TO 8 HOURS.