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

Model Number 055

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Date 02/24/2014

Event Type  malfunction  

Event Description

Caller stated that she got a mild burn on her stomach.

Manufacturer Narrative

Qc could not find any evidence of burning anywhere on or in the pad and switch.

• Brand Name: THERMOPHORE AUTOMATIC HEAT PACK
• Type of Device: ELECTRIC MOIST HEAT PACK
• Manufacturer (Section D): BATTLE CREEK EQUIPMENT; fremont IN
• Manufacturer Contact: randy newsome ; 702 south reed street; fremont, IN 46737 ; 2699626181
• MDR Report Key: 3784581
• MDR Text Key: 4358522
• Report Number: 1811605-2014-00066
• 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: 055
• 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: 10/01/1998
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1