MAUDE Adverse Event Report: KAZ VICKS KAZ VICKS; WARM STEAM VAPORIZER

Model Number V150SG2UPC

Device Problems Device Emits Odor (1425); Particulates (1451); Precipitate in Device or Device Ingredient (1478); Sediment, Precipitate Or Deposit In Device Or Device Ingredient (3021)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/02/2017

Event Type  malfunction  

Event Description

After using this vaporizer, the water in the tank turns black.The water contains small pieces of black flakes.The mist smells of plastic.This occured after day one of use and we thought it would stop after continual use.This has occured after every time it is used and this has been for approximately three years.Mfr date code: 26510ktc.(b)(6).The product was not damaged before the incident: no.The product was not modified before the incident: no.(b)(4).

• Brand Name: KAZ VICKS
• Type of Device: WARM STEAM VAPORIZER
• Manufacturer (Section D): KAZ VICKS
• MDR Report Key: 6266403
• MDR Text Key: 65525364
• Report Number: MW5067339
• Device Sequence Number: 1
• Product Code: KFZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: V150SG2UPC
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 58 YR