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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; STEAM INHALER
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KAZ USA, INC., A HELEN OF TROY COMPANY VICKS; STEAM INHALER Back to Search Results
Model Number V1200
Device Problems Improper or Incorrect Procedure or Method (2017); Device Damaged Prior to Use (2284); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Partial thickness (Second Degree) Burn (2694)
Event Date 05/15/2017
Event Type  Injury  
Manufacturer Narrative
Kaz usa, inc.Has requested that the product be returned for testing, but the product has not yet been received.
 
Event Description
A consumer reported that she received second degree burns on her shoulder from hot water that spilled out of the personal steam inhaler.Medical intervention was sought for their injuries.The consumer stated that she was moving the unit 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", and "caution: do not place on lap or lift in your hands while in operation and if the unit still contains water." kaz usa, inc.Has requested that the product be returned to our company for testing.
 
Event Description
A consumer reported that she received second degree burns on her shoulder from hot water that spilled out of the personal steam inhaler.Medical intervention was sought for their injuries.The consumer stated that she was moving the unit 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", and "caution: do not place on lap or lift in your hands while in operation and if the unit still contains water.".
 
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Brand Name
VICKS
Type of Device
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 Key6646232
MDR Text Key77716044
Report Number1314800-2017-00030
Device Sequence Number1
Product Code KFZ
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 Patient
Type of Report Initial,Followup
Report Date 07/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/16/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberV1200
Device Lot Number15816
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/19/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received05/17/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/08/2016
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; Required Intervention;
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