MAUDE Adverse Event Report: BATTLE CREEK EQUIPMENT THERMOPHORE

Model Number 155

Device Problems Overheating of Device (1437); Improper or Incorrect Procedure or Method (2017)

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

Event Type  malfunction  

Event Description

Customer stated, "pad gets very hot.Too hot and have to shut off, in use i maybe sit on the pad when used on back" customer did not claim injury.Product was returned.The investigator conducted testing for maximum temperatures, possibilities of hot spots, and wattage draw of the device.The investigation supported that the unit was within specification and no defects were observed.Customer admitted to sitting on the product during use.Ifu states, "do not sit on, lie on, or crush pad.Avoid sharp folds".No defects observed.

• Brand Name: THERMOPHORE
• Type of Device: THERMOPHORE
• Manufacturer (Section D): BATTLE CREEK EQUIPMENT; 702 south reed rd; fremont IN 46737
• Manufacturer Contact: michael green
• MDR Report Key: 9511440
• MDR Text Key: 180777586
• Report Number: 1832415-2019-10947
• 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
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 155
• Device Lot Number: 00155305195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2019
• Date Manufacturer Received: 11/27/2019
• Type of Device Usage: N
• Patient Sequence Number: 1