MAUDE Adverse Event Report: BATTLE CREEK EQIPMENT THERMOPHORE

Model Number 155

Device Problems Break (1069); Thermal Decomposition of Device (1071); Improper or Incorrect Procedure or Method (2017); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Customer stated, "the slider button came off." the user did not claim any injury.The product was returned for investigation.An investigation was done to look into the users complaint.The investigator noticed that the cover had a burn hole in it.This was because the user was using the pad behind her in a recliner.The pad got scrunched during use in the recliner, this scrunching lead to the creation of hotspot, this hotspot lead to the burn hole in the cover.

• Brand Name: THERMOPHORE
• Type of Device: THERMOPHORE
• Manufacturer (Section D): BATTLE CREEK EQIPMENT; 702 s. reed road; fremont 46737
• Manufacturer Contact: uday bahal
• MDR Report Key: 8741637
• MDR Text Key: 149626679
• Report Number: 1832415-2019-10543
• 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: 05/28/2019

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: 00155056193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/27/2019
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1