MAUDE Adverse Event Report: HOME HEALTHCARE PRODUCTS INC. DUNLAP HEAT PAD

Model Number 4570-200

Device Problems Fire (1245); Hole In Material (1293); Device Emits Odor (1425)

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

Event Date 08/03/2017

Event Type  No Answer Provided  

Event Description

I was using the heated pad for my lower back pain, while sitting on my couch.I detected a smell while the unit had not yet produced its normal "heat" throughout, so i turned around and then saw a small flame coming out of the cover of the unit.I unplugged it immediately to stop the fire.I was very lucky that the fire did not go through my couch and my clothing, but only made like a "gun hole" in the covers of the unit.This could have ruined my couch, and caused serious burns to my back and clothing.The mfr needs to address this drastic issue with their heat pad units pronto.Document number: (b)(4).

• Brand Name: DUNLAP HEAT PAD
• Type of Device: DUNLAP HEAT PAD
• Manufacturer (Section D): HOME HEALTHCARE PRODUCTS INC.
• MDR Report Key: 6834287
• MDR Text Key: 84242960
• Report Number: MW5071865
• 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: 08/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 4570-200
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1