MAUDE Adverse Event Report: KAZ USA, INC., A HELEN OF TROY COMPANY VICKS; ULTRASONIC HUMIDIFIER

Model Number	VUL565
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Discomfort (2330); Cough (4457)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Kaz usa, inc.Has requested that the product be returned to our company for testing, but it has not yet been received.
Event or Problem Description
A consumer reported that she and her 3 year old daughter had been using vicks vapopads (vsp30fp) with the vul565 device approximately 3-4 months ago.She stated that both experienced significant respiratory harm, including persistent coughing, throat irritation, and nighttime breathing difficulty, which required repeated medical visits, prescription medications, and inhalation therapy.The consumer alleges that the use of vapopads contributed to their respiratory issues and provided information that they were prescribed albuterol inhaler, albuterol nebulizer treatments, fluticasone (inhaled corticosteroid), optichamber pediatric mask, and benzonatate for persistent cough.The consumer did not provide an exact incident date of illness or doctor's visits.The consumer further reported that symptoms improved only after discontinuation of both the humidifier and the vapopads.Kaz usa, inc.Has requested that the product be returned to our company for testing.

• Brand Name: VICKS
• Common Device Name: ULTRASONIC HUMIDIFIER
• Manufacturer (Section D): KAZ USA, INC., A HELEN OF TROY COMPANY; marlborough MA 01752
• Manufacturer Contact: bethany lee ; 400 donald lynch boulevard; suite 300; marlborough, MA 01752 ; 5084907247
• MDR Report Key: 23939718
• Report Number: 1314800-2026-00001
• Device Sequence Number: 18664505
• Product Code: KFZ
• UDI-Device Identifier: 00328785014464
• UDI-Public: 00328785014464
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/01/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: VUL565
• Device Lot Number: 17522
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 01/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/25/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 3 YR
• Patient Sex: Female