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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 055
Device Problem Fire (1245)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/05/2014
Event Type  malfunction  
Event Description
Customer stated the switch caught fire while holding it.
 
Manufacturer Narrative
The user reported the switch caught fire while using it.Upon investigation, we found that the cord had been severed by an external source.Upon further investigation, we found: cord cut: no burns, switch ok, pad bunched, bent/broken lead, bent/broken thermostat, thermostat discoloration.Based on the overall condition of the pad, we concluded that the heating pad was not used in accordance with our instructions.
 
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Brand Name
THERMOPHORE AUTOMATIC HEAT PACK
Type of Device
ELECTRIC MOIST HEAT PACK
Manufacturer (Section D)
BATTLE CREEK EQUIPMENT
fremont IN
Manufacturer Contact
randy newsome
702 south reed street
fremont, IN 46737
2699626181
MDR Report Key3843821
MDR Text Key4615725
Report Number1811605-2014-00121
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 05/23/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/24/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number055
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/14/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received05/14/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2007
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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