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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 155
Device Problems Thermal Decomposition of Device (1071); Hole In Material (1293)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
Customer stated "heating pad has 2 holes with burn marks.About the size of a quarter.She never saw any flames or anything.She notice it when she took her cover off to wash it." the product has not been returned for investigation.Based on the bce review of feedbacks, bce did not observe a similar issue within the lot.Customer did not seek out medical attention.
 
Event Description
The product was returned for investigation.An investigation was done to look into the customers complaint.The investigator noticed discoloration in the heater wire pattern on the pad.The investigator also observed hole with burn marks on the pad.Both of the observations were caused by the customer misusing the pad by folding or laying on the pad during use.This is misuse.The pad was bunched, stained, had bent leads, bent/discolored thermostats and failed harness.This is observed when the pad is folded/ laid on during use.Ifu states "do not sit on, lie on, or crush pad.Avoid sharp folds.".
 
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Brand Name
THERMOPHORE
Type of Device
THERMOPHORE
Manufacturer (Section D)
BATTLE CREEK EQUIPMENT
702 s reed rd
fremont IN 46737
MDR Report Key7245283
MDR Text Key99307421
Report Number1832415-2017-08473
Device Sequence Number1
Product Code IRT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 10/23/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/06/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number155
Device Lot Number1554713
Was the Report Sent to FDA? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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