MAUDE Adverse Event Report: BATTLE CREEK EQUIPMENT THERMOPHORE

Model Number 155

Device Problems Break (1069); Thermal Decomposition of Device (1071)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Customer stated, "pad was not producing heat and the indicator light was off".The product was returned for investigation.The customer did not claim any injury.An investigation was done to look into the customers complaint.The investigator determined the customer was misusing the pad by wrapping the cord during use.The wrapping of the cord led to a break in the internal wiring.The break led to exposed / burnt wiring that the investigator found during investigation.Ifu states, "loop cord loosely when storing.Tight wrapping may damage cord and internal parts.".

• 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: 9122947
• MDR Text Key: 161951150
• Report Number: 1832415-2019-10701
• 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: 08/27/2019

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: 155
• Device Lot Number: 00155205182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1