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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; ELECTRIC STEAM INHALER
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KAZ USA, INC., A HELEN OF TROY COMPANY VICKS; ELECTRIC STEAM INHALER Back to Search Results
Model Number V1200
Device Problem Use of Device Problem (1670)
Patient Problem Partial thickness (Second Degree) Burn (2694)
Event Date 03/19/2019
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 he received second degree burns on his stomach and right arm from hot water that spilled out of the personal steam inhaler.Medical intervention was sought for their injuries at a walk-in clinic.The consumer stated that he was grabbing the unit away from his wife when the injury occurred.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", 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, but the product had already been returned to the retailer.We asked that the consumer contact the retail store to try to recover the unit so that we can test it.
 
Event Description
A consumer reported that he received second degree burns on his stomach and right arm from hot water that spilled out of the personal steam inhaler.Medical intervention was sought for their injuries at a walk-in clinic.The consumer stated that he was grabbing the unit away from his wife when the injury occurred.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", 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
Manufacturer (Section D)
KAZ USA, INC., A HELEN OF TROY COMPANY
marlborough MA 01752
MDR Report Key8523253
MDR Text Key142232035
Report Number1314800-2019-00023
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 04/26/2019
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 Number30918MHD
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/24/2019
Initial Date Manufacturer Received 03/22/2019
Initial Date FDA Received04/17/2019
Supplement Dates Manufacturer Received03/22/2019
Supplement Dates FDA Received04/26/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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