MAUDE Adverse Event Report: BATTLE CREEK EQUIPMENT THERMOPHORE

Model Number 077

Device Problems Thermal Decomposition of Device (1071); Material Puncture/Hole (1504); Naturally Worn (2988)

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

Event Type  malfunction  

Event Description

Customer stated, "took off cover to wash and noticed burn marks on it.Also has burn holes in the pad itself.Customer admitted to laying on the unit." customer did not claim injury.Product was returned.The investigator observed the unit was discolored when received and had a hole determined to be caused by wear and tear over 17 years.The investigator did not observe any evidence of burn marks or burn holes on the unit.The end user admission to laying on the pad would contribute to the extensive wear holes.Ifu states, "do not sit on, lie on, or crush pad.Avoid sharp folds" no defects observed with the unit.

• Brand Name: THERMOPHORE
• Type of Device: THERMOPHORE
• Manufacturer (Section D): BATTLE CREEK EQUIPMENT; 702 s reed rd; fremont IN 46737
• Manufacturer Contact: michael green
• MDR Report Key: 9526605
• MDR Text Key: 177969565
• Report Number: 1832415-2019-10959
• 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: 12/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 077
• Device Lot Number: 022312
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1