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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 VIH200
Device Problems Use of Device Problem (1670); Device Handling Problem (3265); Patient Device Interaction Problem (4001)
Patient Problems Partial thickness (Second Degree) Burn (2694); Full thickness (Third Degree) Burn (2696)
Event Date 04/30/2021
Event Type  Injury  
Event Description
A consumer reported that she received second degree and third degree burns on her abdomen, legs, and groin from hot water that spilled from the personal steam inhaler during use.Medical intervention was sought for her injuries, and follow up care at a burn clinic was also sought.The instructions for proper use have clear warnings which state."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 "do not move, lift, shake, tilt or disassemble while in operation or if it still contains hot water".
 
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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 Key12832558
MDR Text Key280927219
Report Number1314800-2021-00027
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 11/15/2021
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 NumberVIH200
Device Lot Number19720MGH
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/05/2021
Initial Date Manufacturer Received 11/02/2021
Initial Date FDA Received11/17/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/16/2020
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) Required Intervention; Hospitalization; Other;
Patient SexFemale
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