FDA Adverse Event Injury Summary report: N

ICYHOT HEAT THERAPY CHATTEM, INC.

MDR report key: 1069875 · Received July 3, 2008

Report

Report Number
MW5007518
Event Type
Injury
Date Received
July 3, 2008
Report Date
July 3, 2008
Manufacturer
CHATTEN, INC.
Product Code
IMD
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
NJ, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

COPY OF ACTUAL LETTER I SENT TO THE COMPANY, FEBRUARY 13, 2008. REF: ICYHOT HEAT THERAPY, LOT CODE 3A7UD EXP 07/10. DEAR SIR OR MADAM, I PURCHASED THE ABOVE PRODUCT EXPECTING MILD RELIEF FROM A SORE UPPER BACK. A CO-WORKER HELPED ME PLACE THE ICY HOT PAD ON THE SPOT WHERE I WAS FEELING PAIN ON AS DIRECTED. THROUGHOUT THE DAY, I FELT THE HEAT AND A BIT OF RELIEF. FIVE HOURS LATER, WHEN I RETURNED HOME, I PREPARED FOR A SHOWER. UPON GENTLY REMOVING THE ICY HOT PAD, I WAS IN TERRIBLE PAIN. WHEN REMOVING THE PAD GENTLY, MY SKIN WAS ALSO REMOVED IN AN EXTREMELY PAINFUL MANNER. I WAS LEFT WITH THREE -3- LARGE ABRASIONS ON MY BACK. THE ABRASIONS WERE RAW AND PAINFUL. I WAS AFRAID TO PUT ANYTHING ON THE ABRASION IN FEAR OF MORE PAIN. I HAD AN AWFUL NIGHT'S SLEEP DUE TO THE INABILITY TO LIE ON MY BACK AS USUAL. THE FOLLOWING MORNING, I TOOK A SHOWER AND THE LIGHT RUNNING WATER EVEN IRRITATED THE ABRASIONS. LATER THAT AFTERNOON, WITH MY BACK STILL HURTING AND BURNING, I PHONED MY DOCTOR. SHE ADVISED ME TO COME IN SO SHE MAY HAVE A LOOK AT WHAT I WAS TALKING ABOUT. I HAD NOT TOLD HER HOW I GOT THE ABRASIONS. MY DOCTOR WAS SHOCKED WHEN I INFORMED HER OF WHAT HAD HAPPENED AND ADVISED ME TO EMAIL CHATTEM, INC. AND INFORM THE COMPANY OF WHAT I AM EXPERIENCING AND MAYBE PREVENT THIS FROM HAPPENING TO SOMEONE ELSE. I SEARCHED THE INTERNET AND COULD NOT FIND AN AREA TO BE ABLE TO EMAIL CHATTEM, INC., WHICH WAS BOTH ANNOYING AND DISAPPOINTING, AND LEAD ME TO WRITE INSTEAD. BY THE WAY, I DO NOT HAVE SENSITIVE SKIN. I READ ALL THE INSTRUCTIONS BEFORE USING THE ICY HOT PAD. MINOR SKIN IRRITATION IS SOMETHING ONE WOULD EXPECT FROM USING SUCH A PRODUCT. WHAT I AM SUFFERING IS NOT MINOR. MY DOCTOR PRESCRIBED ANTIBIOTIC OINTMENT TO BE ADMINISTERED THREE -3- TIMES DAILY AND TO KEEP THE ABRASIONS COVERED TO PREVENT INFECTION. I WORK IN AN ENVIRONMENT WHERE THE PUBLIC IS IN AND OUT. HAVING TO APPLY OINTMENT AND COVER THE ABRASIONS THREE -3- TIMES DAILY IS BOTH INCONVENIENT AND DEFINITELY NOT A PLEASANT EXPERIENCE. THE WORST PART OF THIS IS THAT I NEED ASSISTANCE WHEN APPLYING THE OINTMENT AND BANDAGES. I SPENT GOOD MONEY ON THIS PRODUCT AND ENDED UP WITH SKIN ABRASIONS AND THROWING THE OTHER TWO -2- ICYHOT PADS AWAY. IN CONCLUSION, I AM EXTREMELY DISAPPOINTED IN YOUR PRODUCT AND FIRMLY BELIEVE THAT YOUR MINOR IRRITATION WARNING IS UNTRUTHFUL AND MISLEADING. A HAPPY CUSTOMER MAY TELL TWO -2- PEOPLE. AN UNHAPPY CUSTOMER TELLS TEN -10-. I AM AN UNHAPPY CUSTOMER. DOSE OR AMOUNT: 1 PATCH. FREQUENCY: 1X FOR 5 HOURS. ROUTE: TOP. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: MID BACK PAIN.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 ICYHOT HEAT THERAPY CHATTEM, INC. HEATING PATCH IMD CHATTEN, INC. 3A7UD

Patients

Seq Age Sex Outcome Treatment
1 42 YR Other