MAUDE Adverse Event Report: BATTLE CREEK EQUIPMENT THERMOPHORE

Model Number 156

Device Problems Bent (1059); Thermal Decomposition of Device (1071); Electrical /Electronic Property Problem (1198); Insufficient Heating (1287)

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

Event Type  malfunction  

Event Description

"customer stated ""the pad is not getting hot and there are burn marks and you can see the wires are bend and coming through the material"".Product was returned for investigation.An investigation was done into the customers complaint.The brown marks on the pad and the appearance of the cord is a result of the customer folding and laying on the product while they were using it.Ifu states ""do not sit on, lie on, or crush pad.Avoid sharp folds."" the pad was tested by a quality control technician and the pad was heating and functioning properly.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: 7245280
• MDR Text Key: 99304892
• Report Number: 1832415-2017-08329
• 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: 09/15/2017

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: 00156021171
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/06/2018
• 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