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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BATTLE CREEK EQUIPMENT THERMOPHORE AUTOMATIC HEAT PACK; ELECTRIC MOIST HEAT PACK
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BATTLE CREEK EQUIPMENT THERMOPHORE AUTOMATIC HEAT PACK; ELECTRIC MOIST HEAT PACK Back to Search Results
Device Problem Thermal Decomposition of Device (1071)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/07/2014
Event Type  malfunction  
Event Description
Customer called and stated that the pad burned through covers, sheet pillow case, shirt and pants.
 
Manufacturer Narrative
Our examination revealed that one of the terminals had been broken near a thermostat, which had compromised our double-insulated design.We also found several other internal components that were damaged, indicating that the customer misused the pad by applying an excessive, localized force on or near the thermostat terminal.We concluded that this report was attributable to misuse by the user, and failure to follow instructions as to the care and handling of the unit.Although warning labels and instruction booklets warn against sitting or layer on the product, we have a corrective action project (b)(4) underway to make the design more robust.
 
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Brand Name
THERMOPHORE AUTOMATIC HEAT PACK
Type of Device
ELECTRIC MOIST HEAT PACK
Manufacturer (Section D)
BATTLE CREEK EQUIPMENT
freemont IN
Manufacturer Contact
randy newsome
702 south reed street
freemont, IN 46737
2699626181
MDR Report Key3788439
MDR Text Key4442149
Report Number1811605-2014-00076
Device Sequence Number1
Product Code IRT
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,User Facility
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 04/01/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/18/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received03/18/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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