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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEMI THERMOPHORE AUTOMATIC HEAT PACK; ELECTRIC MOIST HEAT PACK
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HEMI THERMOPHORE AUTOMATIC HEAT PACK; ELECTRIC MOIST HEAT PACK Back to Search Results
Model Number 085
Device Problem Insufficient Information (3190)
Patient Problem No Information (3190)
Event Date 04/22/2014
Event Type  malfunction  
Event Description
Customer e-mailed problem and pictures.
 
Manufacturer Narrative
Fda: cord cut, broken/missing spring, pad bunches, bent/broken lead, thermostat discoloration.Also found the switch appeared to have been taped down (tape marks) and the black lever was not working.The cord also appeared to have been pulled on, it was pulled away from the strips and lead.Our investigation shows the sparking occurred as the cords was severed.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)
HEMI
freemont MI
Manufacturer Contact
randy newsome
702 south reed st.
freemon, IN 46737
2699626181
MDR Report Key3823769
MDR Text Key4390114
Report Number1811605-2014-00112
Device Sequence Number1
Product Code IRT
Combination Product (y/n)N
Reporter Country CodeHK
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 Number085
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 Manufactured03/01/2012
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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