MAUDE Adverse Event Report: KAZ USA, INC., A HELEN OF TROY COMPANY VICKS; PERSONAL STEAM INHALER

Model Number VIH200

Device Problems Use of Device Problem (1670); Device Handling Problem (3265); Patient Device Interaction Problem (4001)

Patient Problems Partial thickness (Second Degree) Burn (2694); Full thickness (Third Degree) Burn (2696)

Event Date 04/30/2021

Event Type  Injury  

Event Description

A consumer reported that she received second degree and third degree burns on her abdomen, legs, and groin from hot water that spilled from the personal steam inhaler during use.Medical intervention was sought for her injuries, and follow up care at a burn clinic was also sought.The instructions for proper use have clear warnings which state."caution: never move the appliance while in use.It can spill hot water if tilted, shaken or tipped over causing injury or burns", as well as "do not move, lift, shake, tilt or disassemble while in operation or if it still contains hot water".

• Brand Name: VICKS
• Type of Device: PERSONAL STEAM INHALER
• 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: 12832558
• MDR Text Key: 280927219
• Report Number: 1314800-2021-00027
• Device Sequence Number: 1
• Product Code: KFZ
• UDI-Device Identifier: 00328785502008
• UDI-Public: 00328785502008
• 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: 11/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: VIH200
• Device Lot Number: 19720MGH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2021
• Date Manufacturer Received: 11/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization; Other
• Patient Sex: Female