InjuryIME
THERMIPAQ
Received Aug 8, 2017 · Event occurred Sep 27, 2015
Report 3012316249-2017-00094 · MDR key 6773975
Device
Generic name
Clay Therapy Hot Cold Pain Relief Wrap
Manufacturer
Tops Medical Articles IndustriesProduct problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Burn(s)
- Burn(s)
Narrative
Description of Event or Problem
THE USER USED THE PRODUCT IN ITS ORDINARY COURSE, FOLLOWING ALL DIRECTIONS, WHEN SHE SUSTAINED SERIOUS BURNS TO HER UPPER ARM. THE USER IS SUSPECTED TO HAVE EITHER USED THE TPF5302LP HOT/COLD PAIN RELIEF WRAP OR THE TPF5201LP HOT/COLD WRAP THE ORIGINAL PART NUMBER PROVIDED BY THE LAW FIRM (INITIAL REPORTER) WAS LINKED BACK TO A MICROWAVE OVEN (NO EVIDENCE THAT THE MICROWAVE OVEN ITSELF HAD MALFUNCTIONED).