MAUDE Adverse Event Report: BATTLE CREEK EQUIPMENT THERMOPHORE HEATING PAD; ELECTRIC MOIST HEAT PACK

Device Problems Fire (1245); Melted (1385); Device Emits Odor (1425)

Patient Problem No Information (3190)

Event Date 03/17/2014

Event Type  No Answer Provided  

Event Description

Customer stated that he had fire out of the side of the unit, by the timer.Hole melted on the side, smelled like burning plastic.

Manufacturer Narrative

Despite providing a pre-paid return service label, the product in question has not been returned as of the date of this report.

• Brand Name: THERMOPHORE HEATING PAD
• Type of Device: ELECTRIC MOIST HEAT PACK
• Manufacturer (Section D): BATTLE CREEK EQUIPMENT; fremont IN
• Manufacturer Contact: randy newsome ; 702 s reed st; fremont, IN 46737 ; 2699626181
• MDR Report Key: 3779436
• MDR Text Key: 4443945
• Report Number: 1811605-2014-00088
• Device Sequence Number: 1
• Product Code: IRT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Patient Sequence Number: 1