MAUDE Adverse Event Report: BATTLE CREEK EQUIPMENT THERMOPHORE

Model Number 058

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn, Thermal (2530)

Event Type  Injury  

Event Description

Customer stated, " that they were lying in bed taking nap with their legs and feet on the bed warmer.After about an hour they woke up and had a blister on their leg." customer claimed that pad caused a blister.Product has not been returned.Pictures were provided.No product was returned for investigation, however pictures were provided.Review of the provided pictures did not indicate any failures or abnormalities of the bed warmer.Review of reported events for the bedwarmer product found no reported events of burn injuries in a 2 year lookback.Without returned product further determinations cannot be made.Updated.Product was returned on 1/7/2020.Investigator observed no evidence of burn marks.An 8 hour test was conducted.The investigator determined there was no defect and all temperatures where within the expected ranges.Customer claim investigation was inconclusive, no trending of similar events within the last 2 years was found upon further review.

• 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: 9676833
• MDR Text Key: 178744238
• Report Number: 1832415-2020-10912
• 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: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 058
• Device Lot Number: 00058015195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/06/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1