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

Device Problem Fire (1245)

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

Event Date 03/24/2014

Event Type  No Answer Provided  

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.

Event Description

Customer stated that pad caught on fire by the plug.

• Brand Name: THERMOPHORE HEATING PAD
• Type of Device: ELECTRIC MOIST HEAT PACK
• Manufacturer (Section D): BATTLE CREEK EQUIMPMENT; fremont IN
• Manufacturer Contact: randy newsome ; 702 s reed st; fremont, IN 46737 ; 2699626181
• MDR Report Key: 3779422
• MDR Text Key: 22209312
• Report Number: 1811605-2014-00093
• 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: 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