MAUDE Adverse Event Report: HEMI THERMOPHORE AUTOMATIC HEAT PACK; ELECTRIC MOIST HEAT PACK

Model Number 255

Device Problem Sparking (2595)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/13/2014

Event Type  malfunction  

Event Description

Customer called and stated that the pad sparked.

Manufacturer Narrative

Our examination revealed that one of the terminals had been broken near a thermostat, which had compromised our double-insulated design.We also found several other internal components that were damaged, indicating that the customer misused the pad by applying an excessive, localized force on or near the thermostat terminal.We concluded that this report was attributable to misuse by the user, and failure to follow instructions as to the care and handling of the unit.All thermostats were discolored and bent or broken.Several of the leads were bent or broken in half and out of place.Pad was bunched up.Although warning labels and instruction booklets warn against sitting or laying on the product, we have a corrective action project (b)(4) underway to make the design more robust.

• Brand Name: THERMOPHORE AUTOMATIC HEAT PACK
• Type of Device: ELECTRIC MOIST HEAT PACK
• Manufacturer (Section D): HEMI; fremont IN
• Manufacturer Contact: randy newsome ; 702 south reed street; fremont, IN 46737 ; 2699626181
• MDR Report Key: 3784575
• MDR Text Key: 4358524
• Report Number: 1811605-2014-00056
• Device Sequence Number: 1
• Product Code: IRT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 255
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/06/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/06/2014
• Initial Date FDA Received: 03/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1