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U.S. Department of Health and Human Services

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

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KAZ USA, INC., A HELEN OF TROY COMPANY VICKS; PERSONAL STEAM INHALER Back to Search Results
Model Number VIH200V2
Device Problems Use of Device Problem (1670); Device Handling Problem (3265); Patient Device Interaction Problem (4001)
Patient Problem Partial thickness (Second Degree) Burn (2694)
Event Date 03/06/2022
Event Type  Injury  
Event Description
A consumer reported that her son received second degree burns on his torso and right arm from hot water that spilled from the personal steam inhaler.She stated that her son had unknowingly twisted the cover off the unit while it was heating up, and the hot water spilled out of the unit onto himself.Medical intervention was sought for his injuries, as well as several follow up care visits.The instructions for proper use have clear warnings that state "keep out of reach of children", "caution: never move the appliance while in use.It can spill hot water if tilted, shaken or tipped over causing injury or burns", as well as "allow the appliance to cool for at least 20 minutes before moving or refilling it".
 
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Brand Name
VICKS
Type of Device
PERSONAL STEAM INHALER
Manufacturer (Section D)
KAZ USA, INC., A HELEN OF TROY COMPANY
marlborough MA 01752
Manufacturer Contact
sonja wilkinson
400 donald lynch boulevard
suite 300
marlborough, MA 01752
5084907236
MDR Report Key14073186
MDR Text Key288982364
Report Number1314800-2022-00011
Device Sequence Number1
Product Code KFZ
UDI-Device Identifier00328785502008
UDI-Public00328785502008
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 04/11/2022
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
Device Operator Lay User/Patient
Device Model NumberVIH200V2
Device Lot Number29221MGH
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/30/2022
Initial Date Manufacturer Received 03/14/2022
Initial Date FDA Received04/11/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/19/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other; Hospitalization; Required Intervention;
Patient Age9.5 YR
Patient SexMale
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