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

Model Number V1200-6-VV1

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

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

Event Date 06/15/2023

Event Type  Injury  

Event Description

A consumer reported that their child received second degree burns on his stomach from hot water that spilled from the personal steam inhaler during use.Medical intervention was sought for his injuries.The instructions for proper use have clear warnings that state "caution: do not place on lap or lift in your hands while in operation and if the unit still contains water", "the appliance should not be left unattended.Keep out of reach of children", and "never move the appliance while in use.It can spill hot water if tilted or overturned causing injury." kaz usa, inc.Has requested that the product be returned to our company for testing.

Manufacturer Narrative

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

• 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: 17361091
• MDR Text Key: 319395226
• Report Number: 1314800-2023-00008
• Device Sequence Number: 1
• Product Code: KFZ
• UDI-Device Identifier: 00328785002492
• UDI-Public: 00328785002492
• 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: 07/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: V1200-6-VV1
• Device Lot Number: 23015
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2015
• 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): Required Intervention; Other
• Patient Age: 13 YR
• Patient Sex: Male
• Patient Race: White