MAUDE Adverse Event Report: BATTLE CREEK EQUIPMENT THERMOPHORE

Model Number 055

Device Problems Thermal Decomposition of Device (1071); Smoking (1585)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Customer stated "she was going to bed and she positioned the pad and laid down on it.She pressed on the classic switch.Within 2-3 seconds she saw smoke coming up from all around her body.She immediately jumped up.She immediately released and unplugged " product was returned for investigation.The product was approx.22 years and 6 months old when the incident occurred.Upon further investigation into the customers complaint ,the inspector found that the customer had a contained harness burn in their pad.This means that the pad had a small burn, either from years of use or the customer misusing the product for many years, causing the harness to leave a small, contained burn inside the product, it never escaped the inside of the pad.The customer did not seek out medical attention.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: 7193887
• MDR Text Key: 97815645
• Report Number: 1832415-2017-07933
• 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: 05/30/2017

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: 055
• Device Lot Number: 943250
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/16/2018
• 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