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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
Model Number 155
Device Problems Thermal Decomposition of Device (1071); Smoking (1585)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/11/2014
Event Type  malfunction  
Event Description
Customer stated that while using that pad, they saw smoke then a burn mark.
 
Manufacturer Narrative
The user reported that she saw smoke and then a burn mark.Upon further investigation we found: fda: cord cut/burned other location, switch ok, pad bunched, bent/broken thermostat, thermostat discoloration, pad dirty or stained.Based on the overall condition of the pad, we concluded that the heating pad was not used in accordance with our instruction.
 
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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 st.
freemont, IN 46737
2699626181
MDR Report Key3823753
MDR Text Key4401853
Report Number1811605-2014-00110
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,User Facility
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 05/01/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/02/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number155
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/30/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received04/30/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2007
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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