MAUDE Adverse Event Report: BATTLE CREEK EQUIPMENT THERMOPHORE

Model Number 046

Device Problems Thermal Decomposition of Device (1071); Material Puncture/Hole (1504)

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

Event Type  malfunction  

Event Description

Customer noticed after using her pad for the first time back in 2015 that the pad had burn holes.She did not see a fire, spark or smoke and did not smell anything unusual.She just noticed burn holes in her pad after use.The product was returned for investigation.The customer did not claim any injury.An investigation was done to look into the customers complaint.The inspector found that the customer had been misusing the pad by folding the pad while it was in use.The inspector observed that the pad was dirty and bunched.The inside of the pad had bent leads and thermostat discoloration.This is observed when the pad is folded during use.Folding the pad while the pad is in use causes the heater wire to be in close proximity with each other which can create a burn on the pad.The ifu states, "do not sit on, lie on, or crush pad.Avoid sharp folds".The customer stated that the incident that lead to the burn marks happened in 2015.The customer continued to use the damaged pad.The ifu states, "carefully examine before each use.Discard unit if it shows signs of deterioration".

• 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: 8081156
• MDR Text Key: 128198575
• Report Number: 1832415-2018-09797
• 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: 10/19/2018

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: 046
• Device Lot Number: 0462115
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/16/2018
• 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