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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VICKS; ELECTRIC STEAM INHALER
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VICKS; ELECTRIC STEAM INHALER Back to Search Results
Model Number V1200
Device Problem Use of Device Problem (1670)
Patient Problems Burn(s) (1757); Full thickness (Third Degree) Burn (2696)
Event Date 04/29/2020
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 she received burns on her thighs and forearm from hot water that spilled from the personal steam inhaler as the product was being moved.Medical intervention was sought for her injuries.The instructions for proper use have a clear warning that states "the appliance should always be placed on a firm, flat waterproof surface", "caution: do not place on lap or lift in your hands while in operation and if the unit still contains water", "the appliance should not be left unattended.Keep out of reach of children", and "never move the appliance while in use.It can spill hot water if tilted or tipped over causing injury." kaz usa, inc.Has requested that the product be returned to our company for testing.
 
Event Description
A consumer reported that she received burns on her thighs and forearm from hot water that spilled from the personal steam inhaler as the product was being moved.Medical intervention was sought for her injuries.The instructions for proper use have a clear warning that states "the appliance should always be placed on a firm, flat waterproof surface", "caution: do not place on lap or lift in your hands while in operation and if the unit still contains water", "the appliance should not be left unattended.Keep out of reach of children", and "never move the appliance while in use.It can spill hot water if tilted or tipped over causing injury.".
 
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Brand Name
VICKS
Type of Device
ELECTRIC STEAM INHALER
MDR Report Key10279801
MDR Text Key199118936
Report Number1314800-2020-00029
Device Sequence Number1
Product Code KFZ
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,Followup
Report Date 08/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberV1200
Device Lot Number22419MGH
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/23/2020
Date Manufacturer Received06/15/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/12/2019
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; Disability;
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