MAUDE Adverse Event Report: MABIS HEALTHCARE PERSONAL STEAM INHALER VAPORIZER WITH AROMATHERAPY TANK FOR KIDS AND CHILDREN MO

Model Number MARGO MOO

Device Problem Overheating of Device (1437)

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

Event Date 05/19/2016

Event Type  Other  

Event Description

I purchased item "briggs healthcare healthsmart 'margo moo' steam inhaler" marketed as specially design for kids, because my (b)(6) old baby has a cold and instead of ever risking my baby with a dangerous vapor treatment with boiling water, i decided to buy an item that was "safe" and will help her be comfortable.I got the item at (b)(6) but as it was delayed and my baby's cold didn't go away so i went ahead and purchased it for same day delivery at (b)(6).We thoroughly read the instructions, securely fill it and throughly close the lids and put it together then we proceeded to the item on a bench so that the baby will breathe 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 breathe 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 moment's time the mask fell off the inhaler and as i was accommodating it my baby moved and jerked the inhaler and boiling hot water dripping over her burning her mouth, chin and chest.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 imagine something like this could happen - i bought an item for kids!! how could this happen!! my baby suffered second degree burns on her chest and chin.She had blistered in a matter of seconds and had the signs of shock that follow severe burns.We called her pediatrician, applied cold water, gave her tylenol for pain and applied an antibiotics ointment the doctor suggested; yesterday in the morning we took her to the doctor's office and she is in burn treatment.I sent the item that burned the baby back to (b)(6) they picked it yesterday as i could not bear the sigh of it.(b)(6) product came today and i called to return it and explain what happened.They were in shock and said that they will pull it off their site.Please recall this product and do not let another child go through this!! document number: (b)(4).Report number: (b)(4).

• Brand Name: PERSONAL STEAM INHALER VAPORIZER WITH AROMATHERAPY TANK FOR KIDS AND CHILDREN MO
• Type of Device: PERSONAL STEAM INHALER VAPORIZER WITH AROMATHERAPY TANK FOR KIDS AND CHILDREN MO
• Manufacturer (Section D): MABIS HEALTHCARE
• MDR Report Key: 5694255
• MDR Text Key: 46739904
• Report Number: MW5062583
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: MARGO MOO
• Was Device Available for Evaluation?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 4 MO