FDA Adverse Event Injury Summary report: N

THERMACARE BACK AND HIP

MDR report key: 1000008 · Received February 12, 2008

Report

Report Number
MW5005533
Event Type
Injury
Date Received
February 12, 2008
Date of Event
August 14, 2007
Report Date
February 12, 2008
Manufacturer
PROCTER & GAMBLE
Product Code
IMD
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
WV, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

WHILE ON A TRIP, I BEGAN HAVING LOWER BACK PROBLEMS WHILE IN OUR CAR. WHEN WE GOT TO THE CITY AND MET UP WITH FAMILY, WE BEGAN A WALKING TOUR. MY BACK WAS REALLY BOTHERING ME, SO I BEGAN USING THERMACARE FOR BACK WRAP. I HAVE USED IT BEFORE BUT NOT USUALLY WHEN IT IS SO HOT OUTSIDE. I PUT IN ON AROUND 10 AM, AND THEN WENT WALKING. I PUT IT ON OVER MY UNDERGARMENTS AND UNDER A PAIR OF COTTON CAPRI PANTS. BY TIME 5:00 CAME, THE WRAP WAS TWISTED AND SOAKING WET AND MY BACK WAS BURNING. I TOOK OFF THE WRAP. WHEN WE GOT BACK TO THE HOTEL, I HAD MY HUSBAND LOOK AT MY BACK; I HAD 5 ROUND BURN MARKS ACROSS THE LOWER MID-BACK. I DID OF COURSE USE THE THERMACARE AGAIN. WHEN I GOT HOME A FEW DAYS LATER, I WENT TO MY FAMILY DOCTOR FOR THE PAIN AND BECAUSE THE BURNS WERE NOT HEALING. HE SAID 2 OF THE BURNS WERE 2ND DEGREE, AND 3 WERE 1ST DEGREE. HE USED A CLEANING SOLUTION THEN PUT A CREAM ON THE BURNS. HE WROTE ME A PRESCRIPTION FOR THE BURNS WHICH I USED FOR A COUPLE OF WEEKS. I STILL HAVE A COUPLE OF SCARS AFTER ALL THESE MONTHS. I REGRET I DID NOT MAKE MY COMPLAINT WHEN THIS HAPPENED. I HOPE THIS COMPLAINT NOW WILL PROVOKE SOME KIND OF STATEMENT, SO THAT OTHERS DO NOT HAVE THIS EVENT. DATES OF USE: 2007. DIAGNOSIS OR REASON FOR USE: LOWER BACK PAIN.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 THERMACARE BACK AND HIP HEATWRAPS IMD PROCTER & GAMBLE

Patients

Seq Age Sex Outcome Treatment
1 66 YR Other