MAUDE Adverse Event Report: HEALTHSMART HEALTHSMART PERSONAL STEAM INHALER VAPORIZER WITH AROMATHERAPY TANK FOR KIDS

Device Problems Component Falling (1105); Overheating of Device (1437)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 05/18/2016

Event Type  Other  

Event Description

I purchased item "healthsmart personal steam inhaler vaporizer with aromatherapy tank for kids and children, margo moo" as stated marketed as specially designed for kids and children, because my (b)(6) who is in daycare, has a cold and instead of risking my baby with what i considered a dangerous vapor treatment with boiling water, i decided to buy an item that was "safe" and will help her feel better.I got the item at (b)(6) but as it was delayed and my baby's cold was not going away.I went ahead and purchased it for same day delivery at (b)(6) in hope we can bring some relief to my little one.We read the instructions, securely filled it with water and thoroughly closed the lids and put it back together; then we placed the item on a bench so that the baby will breath the steam and we added eucalyptus to help the therapy.I placed the mask on my face to make sure that it was safe to breath the vapor and i so stupidly deemed it safe as the steam was not hot but felt just right.This wednesday (b)(6) 2016 at around 10:30 i decided to let my baby inhale some steam so she would have a good night sleep; we did not put the mask on the baby, only set her facing the inhaler, in a moments time the mask fell off the inhaler and as i was putting it back my baby moved and jerked the inhaler and boiling hot water dripped over her burning mouth, chin and chest, she didn't open it, she did not push it into herself, she just jerked it.At that point i still didn't realize that boiling water fell on my baby as she screamed in pain until i touched it.I never ever could image something like this could happen.I bought an item marketed for kids.How could this happen.This water was hotter than that of a coffee maker.How can this be possible? my baby suffered second degree burns on her chest and chin.She had blisters in a matter of seconds and had the signs of shock that follow severe burns.We called her pediatrician she suggested to apply cold water, give her tylenol for pain and apply an antibiotics ointment, all of which we did.We were told that if the blisters weren't larger then her palm and if the pain and blisters were controlled, we needed not to rush to the emergency room but take her to the doctor's office first thing in the morning, the baby fell asleep, woke up crying at 3:30am as more than 4 hours had past since she had the first dose of tylenol.I gave her another dose, she fell asleep and we waited for morning to come to take her to the doctor's.On thursday (b)(6) 2016 at 8:30am we were the first patient seen at the doctor's, my baby was treated for second degree burns, was prescribed an antibiotic cream and special cleans and cares in order to avoid an infection.I sent the item that burned the baby back to (b)(6) they picked it on thursday (b)(6) 2016 as i could not bear the sight of it.(b)(6) product came also on thursday (b)(6) 2016 i called to return it and explain what happened.They were in shock and said that they will pull it off their site.I hope they do, i hope that this product gets off the market.No child should go through what my baby went through and no mother should feel this afflicting pain and guilt that i am carrying.Please recall this product.

• Brand Name: HEALTHSMART PERSONAL STEAM INHALER VAPORIZER WITH AROMATHERAPY TANK FOR KIDS
• Type of Device: HEALTHSMART PERSONAL STEAM INHALER VAPORIZER WITH AROMATHERAPY TANK FOR KIDS
• Manufacturer (Section D): HEALTHSMART
• MDR Report Key: 5688279
• MDR Text Key: 46278052
• Report Number: MW5062524
• Device Sequence Number: 1
• Product Code: CAF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 05/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/24/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 4 MO
• Patient Weight: 7