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

Model Number HEW3000

Device Problems Unexpected Therapeutic Results (1631); Use of Device Problem (1670)

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

Event Date 04/06/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A consumer stated that she had allegedly received third degree burns on her chest while using a heating pad, and medical attention and follow up treatment were sought for the injury.The consumer stated that she was sleeping while using the heating pad on her body at the time that the injury occurred.The instructions for proper use clearly state ""danger: if used improperly, this product can cause severe burns to skin, and damage to property.", "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.Requested that the product be returned 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: 11827135
• MDR Text Key: 250710068
• Report Number: 1314800-2021-00005
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: HEW3000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/15/2021
• 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
• Patient Outcome(s): Hospitalization; Required Intervention