MAUDE Adverse Event Report: BATTLE CREEK EQUIPMENT THERMOPHORE

Model Number 155

Device Problems Bent (1059); Thermal Decomposition of Device (1071); Material Discolored (1170); Improper or Incorrect Procedure or Method (2017)

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

Event Type  malfunction  

Event Description

Customer stated " pad has a burn hole.Never saw the flames.Took cover off to wash it and saw the hole." the product was returned for investigation.An investigation was done into the customers complaint, and the inspector observed that all components of the product were working properly except for the pad, which had multiple issues.The pad was bunched, the leads were bent, the pad and thermostats were discolored.These indicate that the product was folded during use.Ifu states "do not sit on, lie on, or crush pad.Avoid sharp folds." the hole is due to the misuse of product.The product was approx.4 years old when the incident occurred 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: 7282362
• MDR Text Key: 100602824
• Report Number: 1832415-2017-08820
• 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: 01/08/2018

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: 1555213
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/20/2018
• 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