MAUDE Adverse Event Report: VICKS/ KAZ USA, INC., A HELEN OF TROY COMPANY VICKS VAPOPADS SCENT PADS; HUMIDIFIER, NON-DIRECT PATIENT INTERFACE (HOME-USE)

Health Effect - Clinical Codes	Chest Pain (1776); Hypersensitivity/Allergic reaction (1907); Sore Throat (2396); Cough (4457)
Date of Event	12/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Vick vapopads gave me laryngitis and i have lost my voice.I bought both the lavender & rosemary scent and the menthol.The menthol does not cause any problems.I have tried using the lavender and rosemary scent before and noticed rather quick that is was causing my throat to hurt.When this happened i would change to the menthol pad or just not use a pad at all.I should have thrown the box away because i forgot the scent hurt my throat, so last night i put the lavender & rosemary scent in and fell right asleep.I woke up hours later with an extremely sore throat and painful dry cough.Now, at the end of the day, i have terrible chest pain and coughing and i have lost my voice.

• Brand Name: VICKS VAPOPADS SCENT PADS
• Common Device Name: HUMIDIFIER, NON-DIRECT PATIENT INTERFACE (HOME-USE)
• Manufacturer (Section D): VICKS/ KAZ USA, INC., A HELEN OF TROY COMPANY
• MDR Report Key: 15932955
• Report Number: MW5113668
• Device Sequence Number: 13222075
• Product Code: KFZ
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 12/03/2022

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
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/06/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Disability
• Patient Age: 32 YR
• Patient Sex: Female
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White