MAUDE Adverse Event Report: BATTLE CREEK EQUIPMENT THERMOPHORE

Model Number 156

Device Problems Break (1069); Thermal Decomposition of Device (1071); Material Twisted/Bent (2981)

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

Event Type  malfunction  

Event Description

Customer stated "the light comes on but there is no heat." customer did not claim injury.Product was returned.The investigator observed a burn mark on the inside of the unit by the butterfly.The investigator determined twisting of the wires connecting the cord to the pad caused a break in the cord, which lead to the burn mark.This is a manufactures defect.After further investigation, no additional product was impacted and no additional actions were required.

• Brand Name: THERMOPHORE
• Type of Device: THERMOPHORE
• Manufacturer (Section D): BATTLE CREEK EQUIPMENT; 702 s reed rd; fremont, in
• Manufacturer Contact: michael green
• MDR Report Key: 9702515
• MDR Text Key: 182929673
• Report Number: 1832415-2020-11071
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 156
• Device Lot Number: 00156310181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/12/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1