inforMED
InjuryIME

RA INSTANT COLD THERAPY WRAP

Received Jun 2, 2016

Report 3005182235-2016-00006 · MDR key 5695504

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Product code (IME)
Manufacturer (Tops Medical Articles Industries Nantong Inc)
Model (TMF0362277)

Device

Generic name

Cold Therapy Wrap

Model number

TMF0362277

Product problems

  • Device Handling Problem
  • Device Handling Problem

Patient

16 YR

  • Partial thickness (Second Degree) Burn
  • Partial thickness (Second Degree) Burn

Narrative

Description of Event or Problem

THE CUSTOMER PURCHASED THE WRAP ON (B)(6) 2016. THE USER SPRAINED HER ANKLE PLAYING RUGBY LAST (B)(6), AND DECIDED TO BUY THIS WRAP TO TRY AND HELP HER. SHE LEFT THE WRAP ON HER ANKLE FOR 10 MINUTES. THE USER IS (B)(6) YEARS OLD, AND DOES NOT HAVE ANY KNOWN CIRCULATORY PROBLEMS BEING REPORTED. THE USER WAS BURNED FROM THE WRAP, AND HER SKIN TURNED RED; THE WRAP WAS USED FOR 10 MINUTES. THE USER USED THE WRAP ON A TUESDAY, AND WENT TO SCHOOL ON A WEDNESDAY; THE NURSE AT SCHOOL CALLED AND SAID THAT HER ANKLE HAD BAD BLISTERS. THE USER IS NOT ABLE TO PLAY SPORTS NOW. THE USER HAD A DOCTOR'S APPOINTMENT ON (B)(6) 2016. THE DOCTOR RECOMMENDED THAT SHE USED BURN MEDICATION AND APPLIED WRAPPING TO THE BURN.