FDA Adverse Event Injury Summary report: N

SUNBEAM XPRESS HEAT XL HEATING PAD 12" X 24" WITH HEAT-METER

MDR report key: 7146245 · Received December 26, 2017

Report

Report Number
MW5074222
Event Type
Injury
Date Received
December 26, 2017
Date of Event
October 9, 2017
Report Date
November 30, 2017
Manufacturer
SUNBEAM PRODUCTS INC.
Product Code
IRT
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
CO, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I PURCHASED A SUNBEAM XPRESS HEAT MODEL: 2013-912 XL HEATING PAD FROM (B)(6). I HAVE CHRONIC LOWER BACK PAIN, SHOULDER AND NECK PAIN AS WELL. I SET FOR THE FIRST TIME MY NEW SUNBEAM HEATING PAD TO SETTING 6 AND SET IT TO 2 HOURS. I LAID ON MY BED PROPPED UP AND ABOUT A HALF HOUR LATER I REALIZED MY SHIRT WAS SOAKING WET ON MY RIGHT SIDE AND I FELT THIS INDESCRIBABLE BURNING PAIN. I HAD PLACED THE PAD ON MY LEFT BACK SIDE AND THERE WAS ENOUGH EXTRA THAT FOLDED OVER OF THE HEATING PAD THAT MY OTHER PILLOW PUSHED IT UP AGAINST MY LEFT BREAST. AFTER PULLING UP MY SHIRT, I NOTICED ON THE SIDE OF MY LEFT BREAST, I HAD A LARGE SIZE BURN THAT WAS OOZING, ABOUT 3 IN X 4 IN IN DIAMETER WHICH WAS THE CAUSE OF MY SHIRT BEING WET. THIS HAPPENED BACK ON (B)(6) 2017. I AM STILL TRYING TO GET MY WOUND TO HEAL, THIS IS AFTER SEVERAL VISITS TO MY PRIMARY DOCTOR. SUFFERING INFECTION AND HAVING TO TAKE TWO ROUNDS OF ANTIBIOTICS AND APPLYING SSD CREAM DAILY. I AM NOW PERMANENTLY SCARRED AND NOT YET HEALED AND TODAY IS (B)(6) 2017. THIS PRODUCT OBVIOUSLY NEEDS MORE TESTING AND SHOULD NOT GET SO HOT THAT EVEN WITH THE PAD ON YOU CAN GET THIS BADLY BURNED. REPORT NUMBER: (B)(4). REPORT NUMBER: (B)(4). RETAILER: (B)(6). RETAILER STATES: (B)(6). PURCHASE DATE: 03/01/2015. I STILL HAVE THE PRODUCT IN MY POSSESSION. THE PRODUCT WAS NOT DAMAGED BEFORE THE INCIDENT. THE PRODUCT WAS NOT MODIFIED BEFORE THE INCIDENT. "HAVE YOU CONTACTED THE MFR: NO; IF NOT, DO YOU PLAN TO CONTACT THEM: YES."

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
925427 SUNBEAM XPRESS HEAT XL HEATING PAD 12" X 24" WITH HEAT-METER SUNBEAM XPRESS HEAT XL HEATING PAD 12" X 24" WITH HEAT-METER IRT SUNBEAM PRODUCTS INC. 2013-912

Patients

Seq Age Sex Outcome Treatment
1 43 YR