MAUDE Adverse Event Report: BATTLE CREEK EQUIPMENT THERMOPHORE AUTOMATIC HEAT PACK; ELECTRIC MOIST HEAT PACK

Model Number 177

Device Problems Device Emits Odor (1425); Overheating of Device (1437)

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

Event Date 04/14/2014

Event Type  malfunction  

Event Description

Customer stated that something smelled like it was burning and the pad was getting hotter than it should.

Manufacturer Narrative

Qc tested pad and it was heating and working properly, (136-156).No odor poly cover ok, cord ok, switch ok, pad ok.

• Brand Name: THERMOPHORE AUTOMATIC HEAT PACK
• Type of Device: ELECTRIC MOIST HEAT PACK
• Manufacturer (Section D): BATTLE CREEK EQUIPMENT; freemont IN
• Manufacturer Contact: randy newsome ; 702 south reed st.; freemont, IN 46737 ; 2699626181
• MDR Report Key: 3823756
• MDR Text Key: 17614711
• Report Number: 1811605-2014-00113
• 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: 05/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 177
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1