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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BATTLE CREEK EQUIPMENT THERMOPHORE
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BATTLE CREEK EQUIPMENT THERMOPHORE Back to Search Results
Model Number 055
Device Problems Thermal Decomposition of Device (1071); Smoking (1585); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
The customer stated "woke up to the pad smoking and burned a hole in her mattress, sheets, mattress cover, pillow and the pad." additionally, the customer stated that they "would lay on top of the pad while sleeping and that they had rubber banded the switch down." the customer did not claim any injury.Customer did not return the product for investigation nor provide the product udi.The customer admitted to misusing the pad by laying on the product.Ifu states, "do not sit on, lie on, or crush pad.Avoid sharp folds".The customer admitted to misusing the pad by fastening the switch down.Ifu states, "never tape or tie down the switch.The switch was designed for your safety.Use only as directed".
 
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Brand Name
THERMOPHORE
Type of Device
THERMOPHORE
Manufacturer (Section D)
BATTLE CREEK EQUIPMENT
702 s reed rd
fremont IN 46737
Manufacturer Contact
michael green
702 s reed rd
fremont, IN 
MDR Report Key9262313
MDR Text Key173004245
Report Number1832415-2019-10795
Device Sequence Number1
Product Code IRT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Other
Type of Report Initial
Report Date 10/31/2019
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 Number055
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/31/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Type of Device Usage N
Patient Sequence Number1
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