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T305 BIO-COOL ATC COLD THERAPY UNIT

Received Apr 23, 2001 · Event occurred Mar 3, 2001

Report 1055236-2001-00001 · MDR key 328693

Device

Generic name

Tt1 Equipment

Manufacturer

Deroyal Inc.

Model number

01

Catalog number

T305

Lot number

*

Product problems

  • Use of Device Problem

Patient

26 YR

  • Discomfort
  • Burn, Thermal

Narrative

Description of Event or Problem

A PT CLAIMS THAT THE LOWER, LEFT QUADRANT OF THEIR BACK WAS BURNED WHERE THE COLD THERAPY UNIT TOUCHED THEIR SKIN. THE DEROYAL COLD THERAPY UNIT WITH DEROYAL PAD WAS APPLIED AFTER SURGERY BY THE NURSE AT 4 PM ON THE DAY BEFORE THE EVENT DATE. THE PT, WHO IS ALSO A NURSE, WORE THE PAD CONSTANTLY FOR THE NEXT 17 HOURS. WHILE PT STATED THAT PT UNPLUGGED THE DEVICE AT A RATE OF APPROX EVERY 2 HOURS, PT DID FAIL TO REMOVE THE COOLING PAD AND CHECK THE CONDITION OF THEIR AS THE INSTRUCTIONS FOR THE DEVICE ADVISE TO BE DONE FREQUENTLY. ON THE MORNING OF THE EVENT DATE, THE PT FELT MINOR DISCOMFORT NOT IN THE AREA OF THE SURGICAL INCISION. WHEN PT TOUCHED THE AREA "A HANDFUL OF SKIN" CAME OFF FROM THE AREA OF THEIR BACK WHERE THE TUBING TOUCHED THEIR SKIN. PT SELF ADMINISTERED BURN CREAM AND WOUND DRESSING FOR 9 DAYS UNTIL WOULD HEALED. PT DENIED SEEKING TREATMENT FROM PHYSICIAN BECAUSE PT FELT COMPETENT TO ADMINISTER CARE TO SELF. PT DOES NOT EXPECT ANY PERMANENT INJURY.