MAUDE Adverse Event Report: MABIS HEALTHCARE / /BRIGGS MEDICAL SERVICE CO/ DMS HOLDINGS STEAM INHALER; HUMIDIFIER, NON-DIRECT PATIENT INTERFACE (HOME-USE)

Model Number 40-741-000

Device Problem Defective Device (2588)

Patient Problem Burn(s) (1757)

Event Date 08/13/2020

Event Type  Injury  

Event Description

I was burned on my chin; i filled the water reservoir and used the nasal steamer as directed.It shot out hot water unto my face and burned my skin.Fda safety report id# (b)(4).

• Brand Name: STEAM INHALER
• Type of Device: HUMIDIFIER, NON-DIRECT PATIENT INTERFACE (HOME-USE)
• Manufacturer (Section D): MABIS HEALTHCARE / /BRIGGS MEDICAL SERVICE CO/ DMS HOLDINGS
• MDR Report Key: 10419747
• MDR Text Key: 203488697
• Report Number: MW5096101
• Device Sequence Number: 1
• Product Code: KFZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 08/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 40-741-000
• Device Lot Number: 4774200417
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 34 YR
• Patient Weight: 77