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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 Thermal Decomposition of Device (1071)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/26/2014
Event Type  malfunction  
Event Description
The cord inside the pad started to burn.Black hole on the sheet and mattress pad as she was using it in bed.
 
Manufacturer Narrative
The user reported that the switch sparked.Upon further investigation we found that the cord cut was from misuse.Our investigation shows the sparking occurred as the cord cut was severed.Based on the overall condition of the pad, we concluded that the heating pad was not used in accordance with our instructions.The pad was punched up.Several bent, loose and broken leads were found.As well as bent or broken thermostats that were discolored.Pad was dirty or stained.
 
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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 Key3784550
MDR Text Key4442549
Report Number1811605-2014-00070
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 03/24/2014
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? No
Device Operator Lay User/Patient
Device Model Number055
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer03/18/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/18/2014
Initial Date FDA Received03/24/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2009
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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