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

Device Problem Sparking (2595)

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

Event Date 03/31/2014

Event Type  No Answer Provided  

Event Description

Customer stated that sparks flew out by the switch.

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 south reed street; fremont, IN 49017 ; 2699626181
• MDR Report Key: 3782903
• MDR Text Key: 4439524
• Report Number: 1811605-2014-00101
• 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: 04/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2014
• 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