INSTANT COOLING THERAPY WRAP
Received Aug 26, 2016 · Event occurred Jun 29, 2016
Report 3005182235-2016-00024 · MDR key 5908478
Device
Product problems
- Temperature Problem
- Temperature Problem
Patient
Not reported
- Burn(s)
- Burn(s)
Narrative
Description of Event or Problem
ON (B)(6) 2016, AFTER WORKING OUT AT THE GYM, THE END-USER STOPPED AT A STORE TO PURCHASE THE COOLING WRAP. LATER THAT EVENING, FOLLOWING APPROPRIATE DIRECTIONS, SHE WRAPPED THE BANDAGE AROUND HER KNEE, AND KEPT IT THERE FOR 20 MINUTES, AS INSTRUCTED. AFTER SHE REMOVED THE WRAP, SHE NOTICED A WHITE RESIDUE ON HER SKIN. SHE WIPED THE RESIDUE OFF WITH COLD WATER AND THEREAFTER, WENT TO BED. DURING THE COURSE OF THE NIGHT, WHILE ATTEMPTING TO SLEEP, THE KNEE WHICH HAD BEEN WRAPPED DEVELOPED SEVERE PAIN AND BURNING. ON (B)(6) 2016, SHE WENT TO A HOSPITAL WHERE SHE WAS DIAGNOSED WITH A CHEMICAL BURN. SHE WAS REFERRED TO A BURN UNIT, WHERE SHE WAS TREATED BY A BURN SPECIALIST. THE BURN SPECIALIST IS CONTINUING TO TREAT THE END-USER FOR THE CHECMICAL BURN INJURES SHE SUFFERED.