MAUDE Adverse Event Report: BATTLE CREEK EQUIPMENT THERMOPHORE

Model Number 156

Device Problems Thermal Decomposition of Device (1071); Material Discolored (1170)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Customer stated "the pad is starting to burn holes through the cover." the product was returned for investigation.An investigation was done into the customers complaint.The inspector observed contained browning over the heater wire on pad.The inspector did find evidence that the pad was folded while it was in use.Product was misused.Ifu states "do not sit on, lie on, or crush pad.Avoid sharp folds." the browning over the heater wire on pad is due to the folding of pad while is use.Customer did not claim any injury.Based on the bce review of feedbacks, bce did not observe a similar issue within the lot.

• 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: 7241180
• MDR Text Key: 99101040
• Report Number: 1832415-2017-07511
• 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: 03/02/2017

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: 1562113
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/05/2018
• 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