INSTANT COLD THERAPY WRAP
Received Jul 6, 2016 · Event occurred Mar 20, 2016
Report 3005182235-2016-00010 · MDR key 5773643
Device
Generic name
Instant Cold Therapy Wrap
Manufacturer
Tops Medical Articles IndustriesModel number
TMF0362277Product problems
- Physical Property Issue
- Physical Property Issue
Patient
25 YR
- Burn(s)
- Burn, Thermal
- Burn(s)
- Burn, Thermal
Narrative
Description of Event or Problem
ON (B)(6) 2016, AT 3:14PM, THE CUSTOMER/END-USER PURCHASED AN INSTANT COOLING THERAPY WRAP. AT 3:35PM, ON SAID DATE, THE END-USER APPLIED THE THERAPY WRAP TO HER RIGHT KNEE, WHICH WAS EXPERIENCING SORENESS FROM A PRIOR STRAIN. SHORTLY THEREAFTER, THE END-USER SUFFERED SEVERE BURNS FROM THE WRAP, AND SHE REMOVED IT FROM HER LEG. IT IS HEREIN ALLEGED THAT THE INSTANT COOLING THERAPY WRAP PURCHASED BY THE END-USER WAS DEFECTIVE IN THAT IT CAUSED SEVERE BURNS TO HER RIGHT KNEE AND RIGHT LEG. THE BURNS RUPTURED HER SKIN, AND ARE EXPECTED TO LEAD TO PERMANENT SCARRING, DISFIGUREMENT AND POTENTIAL LOSS OF FUNCTION.