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

Model Number V1200-6-VV3

Device Problems Use of Device Problem (1670); Malposition of Device (2616); Human-Device Interface Problem (2949); Patient Device Interaction Problem (4001)

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

Event Date 01/25/2024

Event Type  Injury  

Event Description

A consumer reported that his child received second degree burns on her thigh from hot water that spilled from the personal steam inhaler.He stated that the lock assembly failed when trying to adjust the flow of steam from the product during use, causing hot water to spill onto the child's thigh.The patient required medical attention for their injuries.The instructions for proper use have clear warnings that state "the appliance should not be left unattended.Keep out of reach of children", "the appliance should always be placed on a firm, flat waterproof surface", "caution: do not place on lap or lift in your hands while in operation and if the unit still contains water" as well as, "never move the appliance while in use.It can spill hot water if tilted or tipped over causing injury.".

• Brand Name: VICKS
• Type of Device: PERSONAL STEAM INHALER
• Manufacturer (Section D): KAZ USA, INC., A HELEN OF TROY COMPANY; marlborough MA 01752
• Manufacturer (Section G): NINGBO DECHANG ELECTRICAL APPLIANCE CO.,LTD; no.2 heyi road; dongjiao industrial district,; yuyao, zhejiang 31540 0; CH 315400
• Manufacturer Contact: sonja wilkinson ; 400 donald lynch boulevard; suite 300; marlborough, MA 01752 ; 5084907236
• MDR Report Key: 18789320
• MDR Text Key: 336344395
• Report Number: 1314800-2024-00004
• Device Sequence Number: 1
• Product Code: KFZ
• 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: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: V1200-6-VV3
• Device Lot Number: 17923DEC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2024
• Date Manufacturer Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2023
• 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; Other
• Patient Age: 5 YR
• Patient Sex: Female