MAUDE Adverse Event Report: BATTLE CREEK EQUIPMENT THERMOPHORE

Model Number 056

Device Problems Break (1069); Thermal Decomposition of Device (1071); Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Customer stated, "wire broke at the switch and burnt where cord comes into switch." the product was returned for investigation.The customer did not claim any injury.The product was approx.(b)(6) years old when the incident occurred.An investigation was done to look into the customers complaint.The investigator found that there was a cut on the cord at the strain relief.This occurred because the user was twisting the cord.The cut led to the burn the customer described.The investigator also determined that the customer was also misusing the pad by folding or laying on the pad during use.Ifu states "do not sit on, lie on, or crush pad.Avoid sharp folds.".

• 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: 8489075
• MDR Text Key: 141313905
• Report Number: 1832415-2019-10272
• 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: 03/08/2019

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: 056
• Device Lot Number: 980431
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/05/2019
• 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