MAUDE Adverse Event Report: KAZ USA, INC. SOFTHEAT; HEATING PAD

Model Number HP980

Device Problem Fire (1245)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/09/2014

Event Type  malfunction  

Event Description

The consumer called to report that a heating pad that she owned was allegedly involved in a house fire.She stated that she had been lying against her heating pad, and then left the house with the heating pad still plugged in.There were no injuries or adverse events reported, but the house was a total loss as a result of this incident.Kaz is attempting to pick up the product for further investigation.

• Brand Name: SOFTHEAT
• Type of Device: HEATING PAD
• Manufacturer (Section D): KAZ USA, INC.; 250 turnpike rd; southborough MA 01772
• Manufacturer Contact: sonja wilkinson ; 250 turnpike rd; southborough, MA 01772 ; 5084907236
• MDR Report Key: 4001398
• MDR Text Key: 21880069
• Report Number: 1314800-2014-00057
• Device Sequence Number: 1
• Product Code: IMA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 06/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: HP980
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1