Vicks VIH200Recalls & reported problems
Kaz USA, Inc. · VICKS STEAM INHALER · Class 1
- Adverse event reports
- 16
- Deaths reported
- 0
- Injuries reported
- 16
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00328785502008), received between Dec 16, 2020 and Jun 19, 2026 — classified as 16 injuries.
The most frequently reported specific device problem is “Use of Device Problem” (16 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Use of Device Problem16
- Patient Device Interaction Problem14
- Device Handling Problem9
- Human-Device Interface Problem7
- Unexpected Therapeutic Results2
- Malposition of Device1
Patient problems
- Partial thickness (Second Degree) Burn11
- Burn(s)3
- Full thickness (Third Degree) Burn3
- Superficial (First Degree) Burn1
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
InjuryJun 19, 2026Use of Device Problem; Human-Device Interface Problem; Patient Device Interaction Problem
A CONSUMER REPORTED THAT SHE RECEIVED SECOND DEGREE BURNS TO HER STOMACH AND LEFT LEG FROM HOT WATER THAT SPILLED WHEN THE BOTTOM PORTION OF HER PERSONAL STEAM INHALER (VIH200) DETACHED. SHE STATED THAT THE DEVICE WAS IN THE LOCKED POSITION WHEN SHE PICKED IT UP, AND THE BOTTOM HOUSING SEPARATED, CAUSING THE HOT WATER TO SPILL AND RESULTING IN MULTIPLE BLISTERS. THE CONSUMER REPORTED THAT SHE WAS TREATED IN AN EMERGENCY ROOM, WHERE SHE WAS DIAGNOSED WITH SECOND DEGREE BURNS. THE INSTRUCTIONS FOR PROPER USE HAVE CLEAR WARNINGS THAT STATE "THE APPLIANCE SHOULD ALWAYS BE PLACED ON A FIRM, FLAT, WATERPROOF AND HEAT-RESISTANT SURFACE. BE SURE THE APPLIANCE IS IN A STABLE POSITION AND THE POWER CORD IS OUT OF THE WAY TO PREVENT THE APPLIANCE FROM BEING OVERTURNED.", AS WELL AS "CAUTION: NEVER MOVE OR DISASSEMBLE THE APPLIANCE WHILE IN USE. IT CAN SPILL HOT WATER IF TILTED, SHAKEN, OR OVERTURNED WHICH MAY LEAD TO INJURY OR BURNS.
Patient problems: Partial thickness (Second Degree) Burn
MAUDE report 25566624 ↗InjuryFeb 14, 2026Use of Device Problem; Human-Device Interface Problem; Patient Device Interaction Problem
A CONSUMER REPORTED THAT WHILE USING A VICKS STEAM INHALER (MODEL VIH200) AS INTENDED, THE WATER RESERVOIR ALLEGEDLY LOOSENED AND DETACHED DURING OPERATION, PURPORTEDLY CAUSING HOT WATER TO SPILL ONTO THE CONSUMER'S LEFT THIGH AND RESULTING IN A BURN. THE CONSUMER ALLEGEDLY SOUGHT MEDICAL EVALUATION FROM A PHYSICIAN. ACCORDING TO THE CERTIFIED PHYSICIAN ASSISTANT'S NOTE IN THE ACCOMPANYING MEDICAL FILE, THE CONSUMER ALLEGEDLY SUFFERED A HOT WATER BURN TO THE LEFT THIGH RESULTING IN A SUPERFICIAL BURN. THE CONSUMER LATER REPORTED THAT THE ORIGINAL UNIT THAT CAUSED THE BURN WAS RETURNED TO AMAZON.COM AFTER IT ALLEGEDLY STOPPED HEATING. THE CONSUMER RECEIVED A REPLACEMENT UNIT AND PROVIDED THE LOT CODE OF THE SECOND UNIT AS 07425. NO ADDITIONAL MEDICAL OUTCOME WAS REPORTED. THE INSTRUCTIONS FOR PROPER USE HAVE CLEAR WARNINGS THAT STATE "CAUTION: NEVER MOVE THE APPLIANCE WHILE IN USE. IT CAN SPILL HOT WATER IF TILTED, SHAKEN OR TIPPED OVER CAUSING INJURY OR BURNS", "DO NOT MOVE, LIFT, SHAKE, TILT OR DISASSEMBLE WHILE IN OPERATION OR IF IT STILL CONTAINS HOT WATER", AS WELL AS "ALLOW THE APPLIANCE TO COOL FOR AT LEAST 20 MINUTES BEFORE MOVING OR REFILLING IT". KAZ USA, INC. HAS REQUESTE
Patient problems: Burn(s)
MAUDE report 24341219 ↗InjuryOct 31, 2025Use of Device Problem; Human-Device Interface Problem; Device Handling Problem; Patient Device Interaction Problem; Use of Device Problem; Human-Device Interface Problem; Device Handling Problem; Patient Device Interaction Problem
A CONSUMER, A REGISTERED NURSE, REPORTED ALLEGEDLY SUSTAINING A BURN INJURY WHILE USING THE VICKS STEAM INHALER (MODEL VIH200). DURING THE FIFTH USE, THE BASE ALLEGEDLY DID NOT LOCK SECURELY, AND WHEN PICKING UP THE DEVICE, IT SEPARATED SPILLING HOT WATER ONTO HER RIGHT UPPER THIGH. SHE REPORTED IMMEDIATE BURNING, FOLLOWED BY BLISTERING AND SCARRING. THE BURN WAS DESCRIBED AS APPROXIMATELY THE SIZE OF A PIE. NO MEDICAL TREATMENT WAS SOUGHT; THE INJURY WAS SELF-TREATED WITH ASSISTANCE FROM HER DAUGHTER. THE INSTRUCTIONS FOR PROPER USE HAVE CLEAR WARNINGS THAT STATE "CAUTION: NEVER MOVE THE APPLIANCE WHILE IN USE. IT CAN SPILL HOT WATER IF TILTED, SHAKEN OR TIPPED OVER CAUSING INJURY OR BURNS", "DO NOT MOVE, LIFT, SHAKE, TILT OR DISASSEMBLE WHILE IN OPERATION OR IF IT STILL CONTAINS HOT WATER", AS WELL AS "ALLOW THE APPLIANCE TO COOL FOR AT LEAST 20 MINUTES BEFORE MOVING OR REFILLING IT". KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING.
Patient problems: Burn(s)
MAUDE report 23444434 ↗InjuryMay 24, 2025Use of Device Problem; Human-Device Interface Problem; Patient Device Interaction Problem; Use of Device Problem; Human-Device Interface Problem; Patient Device Interaction Problem
A CONSUMER REPORTED THAT HER 5-YEAR-OLD SON RECEIVED SECOND DEGREE BURNS ON HIS THIGH AND GENITALS FROM HOT WATER THAT SPILLED FROM THE PERSONAL STEAM INHALER. SHE STATED THAT HER 10-YEAR-OLD DAUGHTER HAD BEEN USING THE DEVICE AND APPROXIMATELY 30 SECONDS AFTER POWERING IT OFF, HER SON GRABBED AND ATTEMPTED TO HANDLE THE UNIT. THE BOTTOM PORTION OF THE DEVICE FELL OFF, CAUSING HOT WATER TO SPILL ONTO THE CHILD AND RESULTING IN HIS INJURIES. MEDICAL INTERVENTION WAS SOUGHT AT AN EMERGENCY ROOM, AND THE CHILD WAS THEN TRANSPORTED TO A CHILDREN'S TRAUMA CENTER WHERE HE WAS DIAGNOSED WITH SECOND DEGREE BURNS. THE INSTRUCTIONS FOR PROPER USE HAVE CLEAR WARNINGS THAT STATE "KEEP OUT OF REACH OF CHILDREN," "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 "ALLOW THE APPLIANCE TO COOL FOR AT LEAST 20 MINUTES BEFORE MOVING OR REFILLING IT."
Patient problems: Partial thickness (Second Degree) Burn
MAUDE report 22082395 ↗InjuryApr 19, 2025Use of Device Problem; Device Handling Problem; Patient Device Interaction Problem; Use of Device Problem; Device Handling Problem; Patient Device Interaction Problem
A CONSUMER REPORTED THAT SHE RECEIVED SECOND DEGREE BURNS ON HER STOMACH AND RIGHT LEG FROM HOT WATER THAT SPILLED FROM THE PERSONAL STEAM INHALER. SHE STATED THAT THE BOTTOM OF THE UNIT SUDDENLY DETACHED WHILE SHE WAS USING THE PRODUCT AND HOT WATER SPILLED OUT OF THE UNIT, RESULTING IN HER INJURIES. MEDICAL INTERVENTION WAS SOUGHT FOR HER INJURIES, AS WELL AS MULTIPLE FOLLOW UP VISITS. THE INSTRUCTIONS FOR PROPER USE HAVE CLEAR WARNINGS THAT STATE "CAUTION: NEVER MOVE OR DISASSEMBLE THE APPLIANCE WHILE IN USE. IT CAN SPILL HOT WATER IF TILTED, SHAKEN, OR OVERTURNED WHICH MAY LEAD TO INJURY OR BURNS.", AS WELL AS "THE APPLIANCE SHOULD ALWAYS BE PLACED ON A FIRM, FLAT, WATERPROOF AND HEAT-RESISTANT SURFACE. BE SURE THE APPLIANCE IS IN A STABLE POSITION AND THE POWER CORD IS OUT OF THE WAY TO PREVENT THE APPLIANCE FROM BEING OVERTURNED." KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING.
Patient problems: Partial thickness (Second Degree) Burn
MAUDE report 21869887 ↗InjuryMar 12, 2025Use of Device Problem; Human-Device Interface Problem; Device Handling Problem; Patient Device Interaction Problem; Use of Device Problem; Human-Device Interface Problem; Device Handling Problem; Patient Device Interaction Problem
A CONSUMER REPORTED THAT HER SHE RECEIVED A FIRST-DEGREE BURN ON HER RIGHT THIGH AND A THIRD-DEGREE BURN ON HER LEFT THIGH FROM HOT WATER THAT SPILLED FROM THE PERSONAL STEAM INHALER. SHE STATED THAT SHE MISTAKENLY GRABBED IT BY THE FACE MASK INSTEAD OF THE BODY, CAUSING THE RESERVOIR TO FALL OFF AND SPLASH HOT WATER ON BOTH OF HER THIGHS, RESULTING IN HER INJURIES. MEDICAL INTERVENTION WAS SOUGHT AT AN EMERGENCY ROOM WHERE THE CONSUMER WAS GIVEN ANTIBIOTICS AND HAD HER LEGS WRAPPED. THE INSTRUCTIONS FOR PROPER USE HAVE CLEAR WARNINGS THAT STATE "CAUTION: NEVER MOVE OR DISASSEMBLE THE APPLIANCE WHILE IN USE. IT CAN SPILL HOT WATER IF TILTED, SHAKEN, OR OVERTURNED WHICH MAY LEAD TO INJURY OR BURNS.", AS WELL AS "THE APPLIANCE SHOULD ALWAYS BE PLACED ON A FIRM, FLAT, WATERPROOF AND HEAT RESISTANT SURFACE. BE SURE THE APPLIANCE IS IN A STABLE POSITION AND THE POWER CORD IS OUT OF THE WAY TO PREVENT THE APPLIANCE FROM BEING OVERTURNED."
Patient problems: Full thickness (Third Degree) Burn; Superficial (First Degree) Burn
MAUDE report 21588797 ↗InjuryMar 29, 2024Use of Device Problem; Human-Device Interface Problem; Patient Device Interaction Problem; Use of Device Problem; Human-Device Interface Problem; Patient Device Interaction Problem
A CONSUMER REPORTED THAT HIS WIFE RECEIVED SECOND DEGREE BURNS ON HER LEG FROM HOT WATER THAT SPILLED FROM THE PERSONAL STEAM INHALER. HE STATED THAT THE TOP HOUSING OF THE UNIT WAS NOT SECURED INTO PLACE DURING USE, AND HOT WATER SPILLED ONTO HER LEG CAUSING INJURIES. THE CONSUMER STATED THAT HIS WIFE WAS TREATED IN AN EMERGENCY ROOM, AND LATER ALSO RECEIVED FOLLOW UP CARE FROM A BURN SPECIALIST. THE INSTRUCTIONS FOR PROPER USE HAVE CLEAR WARNINGS THAT STATE "THE APPLIANCE SHOULD ALWAYS BE PLACED ON A FIRM, FLAT, WATERPROOF AND HEAT RESISTANT SURFACE. BE SURE THE APPLIANCE IS IN A STABLE POSITION AND THE POWER CORD IS OUT OF THE WAY TO PREVENT THE APPLIANCE FROM BEING OVERTURNED.", AS WELL AS, "CAUTION: NEVER MOVE OR DISASSEMBLE THE APPLIANCE WHILE IN USE. IT CAN SPILL HOT WATER IF TILTED, SHAKEN, OR OVERTURNED WHICH MAY LEAD TO INJURY OR BURNS." KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING.
Patient problems: Partial thickness (Second Degree) Burn
MAUDE report 19002878 ↗InjuryJan 24, 2024Use of Device Problem; Human-Device Interface Problem; Patient Device Interaction Problem; Use of Device Problem; Human-Device Interface Problem; Patient Device Interaction Problem
A CONSUMER REPORTED THAT HER SHE RECEIVED SECOND DEGREE BURNS ON HER UPPER RIGHT THIGH FROM HOT WATER THAT SPILLED FROM THE PERSONAL STEAM INHALER. SHE STATED THAT THE TOP OF THE UNIT BECAME LOOSE WHILE SHE WAS USING THE PRODUCT HOT WATER SPILLED OUT OF THE UNIT, RESULTING IN HER INJURIES. MEDICAL INTERVENTION WAS SOUGHT AT AN EMERGENCY ROOM. THE INSTRUCTIONS FOR PROPER USE HAVE CLEAR WARNINGS THAT STATE "CAUTION: NEVER MOVE OR DISASSEMBLE THE APPLIANCE WHILE IN USE. IT CAN SPILL HOT WATER IF TILTED, SHAKEN, OR OVERTURNED WHICH MAY LEAD TO INJURY OR BURNS.", AS WELL AS "THE APPLIANCE SHOULD ALWAYS BE PLACED ON A FIRM, FLAT, WATERPROOF AND HEAT RESISTANT SURFACE. BE SURE THE APPLIANCE IS IN A STABLE POSITION AND THE POWER CORD IS OUT OF THE WAY TO PREVENT THE APPLIANCE FROM BEING OVERTURNED."
Patient problems: Partial thickness (Second Degree) Burn
MAUDE report 18574270 ↗InjuryAug 10, 2023Use of Device Problem; Device Handling Problem; Patient Device Interaction Problem; Use of Device Problem; Device Handling Problem; Patient Device Interaction Problem
A CONSUMER REPORTED THAT SHE RECEIVED THIRD DEGREE BURNS ON HER THIGH FROM HOT WATER THAT SPILLED FROM THE PERSONAL STEAM INHALER. SHE STATED THAT SHE ATTEMPTED TO OPEN THE UNIT DURING USE AND HOT WATER SPILLED OUT OF THE UNIT, RESULTING IN HER INJURIES. MEDICAL INTERVENTION WAS SOUGHT FOR HER INJURIES, AS WELL AS MULTIPLE FOLLOW UP VISITS. THE INSTRUCTIONS FOR PROPER USE HAVE CLEAR WARNINGS THAT 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 "ALLOW THE APPLIANCE TO COOL FOR AT LEAST 20 MINUTES BEFORE MOVING OR REFILLING IT". KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING.
Patient problems: Full thickness (Third Degree) Burn
MAUDE report 17498301 ↗InjuryApr 14, 2023Use of Device Problem; Device Handling Problem; Patient Device Interaction Problem; Use of Device Problem; Device Handling Problem; Patient Device Interaction Problem
A CONSUMER REPORTED THAT HER DAUGHTER RECEIVED SECOND DEGREE BURNS ON HER THIGHS FROM HOT WATER THAT SPILLED FROM THE PERSONAL STEAM INHALER. SHE STATED THAT THE BOTTOM PORTION OF THE UNIT BECAME LOOSE WHILE SHE WAS HOLDING THE DEVICE NEAR HER DAUGHTER'S FACE AND HOT WATER SPILLED OUT OF THE UNIT ONTO THE CHILD, RESULTING IN HER INJURIES. MEDICAL INTERVENTION WAS SOUGHT AT AN URGENT CARE CLINIC. THE INSTRUCTIONS FOR PROPER USE HAVE CLEAR WARNINGS THAT STATE "KEEP OUT OF REACH OF CHILDREN", "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 "ALLOW THE APPLIANCE TO COOL FOR AT LEAST 20 MINUTES BEFORE MOVING OR REFILLING IT".
Patient problems: Partial thickness (Second Degree) Burn
MAUDE report 16743048 ↗InjuryApr 11, 2022Use of Device Problem; Device Handling Problem; Patient Device Interaction Problem; Use of Device Problem; Device Handling Problem; Patient Device Interaction Problem
A CONSUMER REPORTED THAT HER SON RECEIVED SECOND DEGREE BURNS ON HIS TORSO AND RIGHT ARM FROM HOT WATER THAT SPILLED FROM THE PERSONAL STEAM INHALER. SHE STATED THAT HER SON HAD UNKNOWINGLY TWISTED THE COVER OFF THE UNIT WHILE IT WAS HEATING UP, AND THE HOT WATER SPILLED OUT OF THE UNIT ONTO HIMSELF. MEDICAL INTERVENTION WAS SOUGHT FOR HIS INJURIES, AS WELL AS SEVERAL FOLLOW UP CARE VISITS. THE INSTRUCTIONS FOR PROPER USE HAVE CLEAR WARNINGS THAT STATE "KEEP OUT OF REACH OF CHILDREN", "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 "ALLOW THE APPLIANCE TO COOL FOR AT LEAST 20 MINUTES BEFORE MOVING OR REFILLING IT".
Patient problems: Partial thickness (Second Degree) Burn
MAUDE report 14073186 ↗InjuryNov 17, 2021Unexpected Therapeutic Results; Use of Device Problem; Unexpected Therapeutic Results; Use of Device Problem
A CONSUMER REPORTED THAT HER SON RECEIVED SECOND DEGREE BURNS THE LEFT SIDE OF HIS BODY FROM HOT WATER THAT SPILLED FROM THE PERSONAL STEAM INHALER WHEN THE CHILD PICKED UP THE PRODUCT DURING USE BY THE FATHER. MEDICAL INTERVENTION WAS SOUGHT FOR HIS INJURIES, AND FOLLOW UP CARE WAS ALSO SOUGHT. THE INSTRUCTIONS FOR PROPER USE HAVE CLEAR WARNINGS WHICH STATE "KEEP OUT OF REACH OF CHILDREN.", "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". KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING.
Patient problems: Partial thickness (Second Degree) Burn
MAUDE report 12832559 ↗InjuryNov 17, 2021Use of Device Problem; Device Handling Problem; Patient Device Interaction Problem; Use of Device Problem; Device Handling Problem; Patient Device Interaction Problem
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".
Patient problems: Full thickness (Third Degree) Burn; Partial thickness (Second Degree) Burn
MAUDE report 12832558 ↗InjuryJul 2, 2021Unexpected Therapeutic Results; Use of Device Problem; Unexpected Therapeutic Results; Use of Device Problem
A CONSUMER REPORTED THAT HE RECEIVED BURNS ON HIS CHEST FROM HOT WATER THAT SPILLED FROM THE PERSONAL STEAM INHALER DURING USE. MEDICAL INTERVENTION WAS SOUGHT FOR HIS INJURIES. THE INSTRUCTIONS FOR PROPER USE HAVE CLEAR WARNINGS THAT 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". KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING.
Patient problems: Burn(s)
MAUDE report 12109066 ↗InjuryJun 1, 2021Use of Device Problem; Device Handling Problem; Patient Device Interaction Problem; Use of Device Problem; Device Handling Problem; Patient Device Interaction Problem
A CONSUMER REPORTED THAT SHE RECEIVED SECOND DEGREE BURNS ON HER RIGHT THIGH FROM HOT WATER THAT SPILLED FROM THE PERSONAL STEAM INHALER WHEN THE PRODUCT WAS ACCIDENTALLY SPILLED WHILE SHE WAS HOLDING THE UNIT IN HER HANDS. MEDICAL INTERVENTION WAS SOUGHT FOR HER INJURIES, AS WELL AS FOLLOW UP CARE AT A BURN CLINIC. THE INSTRUCTIONS FOR PROPER USE HAVE CLEAR WARNINGS THAT 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".
Patient problems: Partial thickness (Second Degree) Burn
MAUDE report 11916206 ↗InjuryDec 16, 2020Use of Device Problem; Malposition of Device; Device Handling Problem; Patient Device Interaction Problem; Use of Device Problem; Malposition of Device; Device Handling Problem; Patient Device Interaction Problem
A CONSUMER REPORTED THAT HER SON RECEIVED SECOND DEGREE BURNS ON HER HIS LEFT THIGH FROM HOT WATER THAT SPILLED FROM THE PERSONAL STEAM INHALER WHEN THE PRODUCT WAS ACCIDENTALLY DROPPED. MEDICAL INTERVENTION WAS SOUGHT FOR HIS INJURIES, AS WELL AS FOLLOW UP CARE AT A BURN UNIT. THE INSTRUCTIONS FOR PROPER USE HAVE CLEAR WARNINGS THAT STATE "KEEP OUT OF REACH OF CHILDREN.", "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". KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING.
Patient problems: Partial thickness (Second Degree) Burn
MAUDE report 11015706 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.