MAUDE Adverse Event Report: SUNBEAM HEATING PAD

Model Number W30402EA 832

Device Problems Thermal Decomposition of Device (1071); Overheating of Device (1437); Smoking (1585)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/05/2017

Event Type  No Answer Provided  

Event Description

The submitter's husband plugged the heating pad to the wall and turned it on to a medium / low heating level.He then placed the heating pad on his back.Approx 5 minutes later, the submitter's husband noticed the heating pad was very hot and when he took it off his back he noticed it was smoking.The submitter's husband unplugged the heating pad and threw it outside of his home.The submitter indicated that the heating pad stopped smoking after a few minutes but it remained hot for a few hours.The submitter indicated that the heating pad has burn holes in the top, in the middle and on the right side.She also said the wires are all black and she has pictures of the damages.The submitter emailed the firm and informed them about the incident (case #(b)(4).) she received a response yesterday, asking her to contact them via phone and provide the numbers found on the prongs.The submitter plans to call the firm.Document number: (b)(4).Report number: (b)(4).

• Brand Name: HEATING PAD
• Type of Device: HEATING PAD
• Manufacturer (Section D): SUNBEAM
• MDR Report Key: 6838745
• MDR Text Key: 84934282
• Report Number: MW5071905
• Device Sequence Number: 1
• Product Code: ILY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: W30402EA 832
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1