FDA Adverse Event Injury Summary report: N

THERMOPHORE

MDR report key: 4671572 · Received April 6, 2015

Report

Report Number
MW5041973
Event Type
Injury
Date Received
April 6, 2015
Date of Event
December 17, 2014
Report Date
March 19, 2015
Manufacturer
BATTLE CREEK EQUIPMENT COMPANY
Product Code
IRT
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
CT, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I USED A THERMOPHORE MOIST HEAT HEATING PAD, WHICH FEATURES A "SAFETY" SWITCH THAT REQUIRES THE USER TO HOLD DOWN THE HANDLE TO WARM THE PAD, SO THAT IF THE USER FALLS ASLEEP AND RELAXES THEIR HAND, THE SWITCH WILL TURN OFF. THE EVENING OF (B)(6) 2014, I MOVED MY THERMOPHORE HEATING PAD OFF TO THE SIDE OF THE BED AND FELL ASLEEP. AT SOME POINT, I ROLLED OVER ONTO THE HEATING PAD AND THE HANDLE WAS PRESSED DOWN, TURNING THE HEAT ON. I WOKE IN EXCRUCIATING PAIN, WITH THE HEATING PAD STUCK TO MY ARM, HAVING RECEIVED WHAT I WAS LATER TOLD WERE 2ND AND 3RD DEGREE BURNS. I CONTACTED MY INTERNIST WHO PRESCRIBED SILVADENE WHICH IS USED TWICE A DAY. WITHIN A WEEK IT WAS APPARENT THAT THE BURNS WERE INFECTED AND I WENT TO AN URGENT CARE CENTER ON (B)(6) 2014. THE PHYSICIAN CLEANED AND DRESSED THE WOUND AND PRESCRIBED CEPHALEXIN 500 MG. I WENT TO MY PRIMARY CARE PHYSICIAN ON (B)(6) 2015 AND SHE PUT ME ON ANOTHER COURSE OF CEPHALEXIN AND SUGGESTED I GO TO THE WOUND CARE CENTER BECAUSE THE BURNS WEREN'T HEALING CORRECTLY. ON (B)(6) 2015, I HAD THE BURNS DEBRIDED AND RETURNED FOR FOLLOW-UP CARE ON (B)(6). THE BURNS CONTINUE TO HEAL, BUT I HAVE SHARP PAIN AT TIMES AND MAY NEED TO RETURN TO THE WOUND CARE CENTER TO MAKE SURE THE HEALING PROCESS IS ON COURSE, OR FOR ADDITIONAL TREATMENT. THERMOPHORE MODEL 055 (FROM BATTLE CREEK EQUIPMENT CO WEBSITE). NEARLY TWICE THE SIZE OF MOST STANDARD HEATING PADS. PROVIDING AN AREA OF HEAT THERAPY LARGE ENOUGH TO COVER THE ENTIRE SPINAL AREA, THE LENGTH OF A HIP AND LEG OR ALL ACROSS BOTH SHOULDERS, TO EFFECTIVELY RELIEVE PAIN AND RELAX ALL THE ASSOCIATED MUSCLES - NOT JUST ONE SMALL, ISOLATED POINT. ORIGINAL THERMOPHORE AUTOMATIC MOIST HEAT PACK IS DESIGNED WITH A SPECIAL HAND-HELD SWITCH. JUST PRESS FOR HEAT, RELEASE TO COOL AND ALTERNATE AS OFTEN AS YOU LIKE. IF YOU HAPPEN TO DOZE OFF AND YOUR HAND RELAXES, THE UNIT WILL COOL AS A SAFETY FEATURE. PURCHASED FROM: (B)(6). PURCHASE DATE: (B)(6) 2013.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
226087 THERMOPHORE ELECTRIC MOIST HEAT PACK IRT BATTLE CREEK EQUIPMENT COMPANY 055

Patients

Seq Age Sex Outcome Treatment
1 55 YR Required Intervention