MAUDE Adverse Event Report: DR RELIEF XXX-L HEATING PAD POWERED; HEATING PAD AND POWERED

Device Problem Thermal Decomposition of Device (1071)

Patient Problem Burn, Thermal (2530)

Event Date 12/21/2018

Event Type  No Answer Provided  

Event Description

Purchased an electric heating pad from (b)(6) in (b)(6) 2018.I had it plugged in and set time to go off during the night.I awoke to burning on my back.When i went to grab the heating pad i then burnt my fingers and hand.It burnt through to my mattress.I have pictures if you would like to see them.Purchase date: (b)(6) 2018.Retailer: (b)(6).(b)(4).

• Brand Name: DR RELIEF XXX-L HEATING PAD POWERED
• Type of Device: HEATING PAD AND POWERED
• MDR Report Key: 8491846
• MDR Text Key: 141319445
• Report Number: MW5085639
• Device Sequence Number: 1
• Product Code: IRT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/05/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 56 YR