MAUDE Adverse Event Report: KAZ USA, INC., A HELEN OF TROY COMPANY WALGREENS; WARM STEAM VAPORIZER

Model Number 2100-WGN

Device Problems Use of Device Problem (1670); Patient Device Interaction Problem (4001)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 09/11/2022

Event Type  Injury  

Event Description

A consumer called and stated that their child accidentally got tangled with the vaporizer's cord during operation, which caused the unit to spill hot water onto the child.The child received medical treatment at an emergency room for second degree burns, and she also required follow up care for these injuries.The instructions for proper use have very clear warnings that state,"warning: keep out of reach of children", as well as "the vaporizer should always be placed on a firm, flat, waterproof, surface at least four feet away from bedside, six inches from the wall and out of the reach of children and pets.Be sure appliance is in a stable position and the power cord is away from heated surfaces and out of the way to prevent the vaporizer from being overturned.".

• Brand Name: WALGREENS
• Type of Device: WARM STEAM VAPORIZER
• 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: 15589472
• MDR Text Key: 301632744
• Report Number: 1314800-2022-00017
• Device Sequence Number: 1
• Product Code: FLL
• UDI-Device Identifier: 00049022459779
• UDI-Public: 00049022459779
• 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: 10/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 2100-WGN
• Device Lot Number: 10322KTC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2022
• Date Manufacturer Received: 09/14/2022
• Date Device Manufactured: 04/13/2022
• 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
• Patient Age: 7 YR
• Patient Sex: Female