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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 V1200
Device Problems Unexpected Therapeutic Results (1631); Use of Device Problem (1670); Device Tipped Over (2589)
Patient Problem Partial thickness (Second Degree) Burn (2694)
Event Date 09/27/2021
Event Type  Injury  
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 Description
A consumer reported that her child received second degree burns on her leg from hot water that spilled from the personal steam inhaler.She reported that her daughter accidentally pulled on the power cord while trying to get up, and the unit tipped over causing her injuries.The child was treated in a hospital for three days, and follow up care will also be required.The instructions for proper use have clear warnings that state "caution: never move or lift the inhaler while it is in use.Do not remove the inhaler hood and vent assembly after turning on the inhaler.Steam is produced by boiling water; tilting can cause water spill and possible burns", "the appliance should always be placed on a firm, flat waterproof surface.Be sure the appliance is in a stable position and the power cord is out of the way to prevent the unit from being tipped over", as well as "the appliance should not be left unattended.Keep out of reach of children".Kaz usa, inc.Has requested that the product be returned to our company for testing.
 
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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
MDR Report Key12698644
MDR Text Key278392162
Report Number1314800-2021-00020
Device Sequence Number1
Product Code KFZ
UDI-Device Identifier00328785002492
UDI-Public00328785002492
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial
Report Date 10/25/2021
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 NumberV1200
Device Lot Number28816
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/27/2021
Initial Date FDA Received10/26/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/16/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other; Required Intervention;
Patient Age8 YR
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