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

Model Number 055

Device Problems Thermal Decomposition of Device (1071); Hole In Material (1293)

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

Event Date 10/03/2014

Event Type  malfunction  

Event Description

The customer called and reported there was a black burn hole on the center panel below the tag.

Manufacturer Narrative

It was reported the fabric foundation of the unit was burned by an internal component.Our examination revealed that one of the terminal had been broken near a thermostat, resulting in a spark which had caused a 1/4" burn hole in one side (both sides) of the fabric foundation.This type of incident is normally caused by misuse on the part of the consumer.Our examination also found: cord ok, switch ok, pad bunched, bent/broken lead, ben/broken thermostat, thermostat discoloration, pad dirty or strained, pad stitching loose/open.

• Brand Name: THERMOPHORE AUTOMATIC HEAT PACK
• Type of Device: ELECTRIC MOIST HEAT PACK
• Manufacturer (Section D): HEMI; fremont IN
• Manufacturer Contact: randy newsome ; 702 s reed st; fremont, IN 46737 ; 2699626181
• MDR Report Key: 4236342
• MDR Text Key: 5075785
• Report Number: 1811605-2014-00211
• 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: 10/28/2014

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: 055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/16/2014
• Initial Date FDA Received: 10/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1