inforMED
InjuryIME

INSTANT COOLING THERAPY WRAP

Received Aug 26, 2016 · Event occurred Jun 29, 2016

Report 3005182235-2016-00024 · MDR key 5908478

Device

Generic name

Cold Reusable Wrap

Model number

TMF0362277

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.