MAUDE Adverse Event Report: BATTLE CREEK EQUIPMENT THERMOPHORE

Model Number 155

Device Problems Break (1069); Thermal Decomposition of Device (1071); Material Puncture/Hole (1504); Use of Device Problem (1670); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Customer stated, "switch was loose"; the product has returned for investigation.The customer did not claim any injury.An investigation was done to look into the customers complaint.The investigation found that the switch was broken and the slider wouldn't move.During investigation.The investigator observed exposed heater wire.The investigator determined the customer was misusing the pad by folding the pad during use.This caused a hotspot to form and caused the burn hole in the material which lead to the exposed heater wire.The 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: uday bahal
• MDR Report Key: 8661523
• MDR Text Key: 146903764
• Report Number: 1832415-2019-10475
• 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: 05/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 155
• Device Lot Number: 00155258173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/02/2019
• 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