MAUDE Adverse Event Report: KAZ USA, INC., A HELEN OF TROY COMPANY SOFTHEAT; HEATING PAD

Model Number HP215

Device Problem Use of Device Problem (1670)

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Date 03/10/2019

Event Type  Injury  

Manufacturer Narrative

Kaz usa, inc.Has requested that the product be returned to our company for testing, but it has not yet been received.

Event Description

A consumer allegedly received third degree burns on her abdomen while using a heating pad, and medical attention was sought for her injuries multiple times.The consumer stated that this incident occurred while she was sleeping on top of the heating pad.The instructions for proper use clearly state "do not use while sleeping", and "this heating pad is intended for use on top of your body.Do not sit or lie on top of the heating pad.Never place pad between yourself and chair, sofa, bed or pillow." kaz usa, inc.Has requested that the product be returned to our company for testing.

• Brand Name: SOFTHEAT
• Type of Device: HEATING PAD
• Manufacturer (Section D): KAZ USA, INC., A HELEN OF TROY COMPANY; marlborough MA 01752
• Manufacturer Contact: sonja wilkinson ; 400 donald lynch boulevard; suite 300; marlborough, MA 01752 ; 5084907236
• MDR Report Key: 10955156
• MDR Text Key: 219771704
• Report Number: 1314800-2020-00038
• Device Sequence Number: 1
• Product Code: IRT
• 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: company representative,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: HP215
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 11/05/2020
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR