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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 056
Device Problems Thermal Decomposition of Device (1071); Overheating of Device (1437); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
Customer stated, switch case and cord got very hot and smelled burnt." customer did not claim injury.Product was returned.Investigator observed evidence of customer misuse of the product by wrapping/ twisting the cord which attributed to the strain relief of the cord being damaged.Additionally there was adhesive residue on the cord for the momentary switch from evident taping of the switch down which is determined as customer misuse of the device.Investigator determined the customer misuse of wrapping/ twisting the cord caused the reported issue of burnt smell and heat at the switch of the cord.The ifu states, "loop cord loosely when storing.Tight wrapping may damage cord and internal parts." the 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
MDR Report Key9503618
MDR Text Key177385181
Report Number1832415-2019-10941
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
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 Number056
Device Lot Number020531
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/27/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/20/2019
Type of Device Usage N
Patient Sequence Number1
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