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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 046
Device Problems Thermal Decomposition of Device (1071); Device Emits Odor (1425); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
Customer stated "husband was chair leaning against pad and wife smelled something, smelled like wires and she check pad saw brown mark on pad like it was burning through" product was returned for investigation.An investigation was done into the customers complaint, and it appeared as though the customer had been folding or laying on the pad while it was in use, causing the heater wire to touch and thus creating a hotspot.Ifu states "do not sit on, lie on, or crush pad.Avoid sharp folds" based on the bce review of feedbacks, bce did not observe a similar issue within the lot.Customer did not claim any injury.
 
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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
uday bahal
MDR Report Key7193891
MDR Text Key97814871
Report Number1832415-2017-08096
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
Report Date 07/13/2017
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 Number046
Device Lot Number460516
Was the Report Sent to FDA? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/16/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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