MAUDE Adverse Event Report: BATTLE CREEK EQUIPMENT THERMOPHORE

Model Number 155

Device Problems Thermal Decomposition of Device (1071); Material Puncture/Hole (1504); Improper or Incorrect Procedure or Method (2017); Material Protrusion/Extrusion (2979)

Patient Problem Burn, Thermal (2530)

Event Type  Injury  

Event Description

Customer stated, "she noticed burn marks on her back." the product has been returned for investigation.The product was approx.5 years and 9 months old when the incident occurred.An investigation was done to look into the customers complaint.The investigator observed exposed heater wire in the pad due to burn holes on the duck cover of the pad.User was misusing the product by laying and/or folding pad during use.Ifu states, "do not sit on, lie on, or crush pad.Avoid sharp folds".Misuse also lead to compromised heater wire layout.Compromised heater wire layout and laying on/folding pad during use lead to creation of hotspots which caused burn holes in pad duck cover and probably user issue.

• 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: 8661285
• MDR Text Key: 146769890
• Report Number: 1832415-2019-10469
• 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: 05/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: 155
• Device Lot Number: 1553013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/01/2019
• 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