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

Model Number	VIH200WMV2
Medical Device Problem Codes	Unexpected Therapeutic Results (1631); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Erythema (1840); Blister (4537)
Date of Event	03/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter called regarding vicks sinus nasal inhaler humidifier.The reporter mentioned that her niece was using the device on her baby as the baby was suffering from chest congestion.The humidifier caused the baby's chest burn with redness and blisters and the mother got scald on her chest.This information was relayed to kaz usa, inc.Through medwatch form #mw5153521; the consumer had never previously contacted our company.We reached out to the consumer's relative who was unsure of the extent of any injuries, and unsure exactly how the product was being used when the alleged incident occurred.The patients involved were the initial reporter's niece, and the niece's infant child.Kaz usa, inc has requested that the product be returned to our company for testing.
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.

• Brand Name: VICKS SINUS INHALER PERSONAL STEAM INHALER
• Common Device Name: PERSONAL STEAM INHALER
• Manufacturer (Section D): KAZ USA, INC., A HELEN OF TROY COMPANY; marlborough MA 01752
• Manufacturer Contact: bethany lee espie ; 400 donald lynch boulevard; suite 300; marlborough, MA 01752 ; 5084907247
• MDR Report Key: 19229928
• Report Number: 1314800-2024-00011
• Device Sequence Number: 14869071
• Product Code: KFZ
• UDI-Device Identifier: 00328785005820
• UDI-Public: 00328785005820
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: Other,Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/02/2024

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: VIH200WMV2
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2024
• Initial Report FDA Received Date: 05/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 8 MO
• Patient Sex: Male
• Patient Weight: 8 KG