MAUDE Adverse Event Report: BATTLE CREEK EQUIPMENT THERMOPHORE

Model Number 056

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Customer stated "pad is working fine.She took the cover off to rearrange the pad and seen a small burn hole in the pad itself." product was returned.Customer did not claim injury.Investigator observed a small burn hole on the pad.The investigator determined the burnt hole was caused by a hot spot related to damaged internal components.The investigator determined that the damage was caused by the user misusing the product by laying on/ folding the pad while in use.Ifu states, "do not sit on, lie on, or crush pad.Avoid sharp folds".

• Brand Name: THERMOPHORE
• Type of Device: THERMOPHORE
• Manufacturer (Section D): BATTLE CREEK EQUIPMENT; 702 s reed rd; fremont IN 46737
• Manufacturer Contact: michael green
• MDR Report Key: 9340986
• MDR Text Key: 174469306
• Report Number: 1832415-2019-10859
• 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
• Report Date: 10/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 056
• Device Lot Number: 00056107171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1