U-P REUS H/C 5X10.5 BULK 12/CA
Received Jan 9, 2013 · Event occurred Dec 4, 2012
Report 2183164-2013-00001 · MDR key 2923255
Device
Product problems
- Improper or Incorrect Procedure or Method
Patient
38 YR
- Inflammation
- Pain
- Partial thickness (Second Degree) Burn
Narrative
Additional Manufacturer Narrative
SUBMIT DATE: (B)(4) 2013. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem
IT WAS REPORTED TO COVIDIEN ON (B)(6) 2012 THAT A CUSTOMER HAD AN ISSUE WITH A HOT/COLD PACK. THE CUSTOMER REPORTS THAT SHE WAS SUFFERING FROM TENDINITIS ON (B)(6) 2012. SHE APPLIED ONE GEL PACK UNDER EACH FOREARM WITH AN ACE BANDAGE WITHOUT APPLYING ANY PROTECTION BETWEEN ARM AND GEL PACK. SHE THEN FELL ASLEEP FOR ONE HOUR. THAT NIGHT SHE WENT TO ER COMPLAINING OF PAIN AND BLISTERING AND WAS TOLD THAT SHE HAD RECEIVED 2ND DEGREE FROST BITE FROM HER ELBOWS TO ABOUT 3 INCHES FROM HER WRISTS. SHE WAS INSTRUCTED TO GO TO THE BURN UNIT AT IOWA CITY HOSPITAL ON (B)(6) 2012 WHERE THE 2ND DEGREE FROST BITE WAS CONFIRMED. AT THE BURN UNIT, SHE WAS TREATED WITH IV AND MORPHINE. SHE RECEIVED SILVER PADS AND SLEEVES FOR TREATMENT. SHE IS CURRENTLY USING OTC 600 MG IBUPROFEN FOR PAIN. SHE WENT FOR A CHECK-UP AT THE BURN UNIT ON (B)(6) 2012 AND THE DOCTOR REPORTS THAT A SKIN GRAFT WILL NOT BE NECESSARY. THE SKIN IS HEALING AS EXPECTED.