MAUDE Adverse Event Report: BIGWALL ENTERPRISES WALGREENS PERSONAL WARM STEAM INHALER

Model Number PJ1011

Event Date 05/06/2015

Event Type  Injury  

Event Description

Consumer reported that when using a steam inhaler product water/steam came out of the machine and caused burns to the user's face.Consumer indicated that they were treated by urgent case and a dermatologist for alleged second degree burns.The consumer's complaint is provided with this report as attachment a.This complaint has been provided to the manufacturer who was able to recover the product from the consumer and has informed walgreens that they are investigating the incident.The incident was originally reported to walgreens with the wrong product number.On 07/14/2015, walgreens learned that the product involved was the walgreens personal steam inhaler (walgreens wic (b)(4)).At (b)(6) pregnant i was having challenges with nasal congestion and breathing so my husband went to (b)(6) and the associate recommended one of the best decongestant options would be the walgreens personal steam inhaler.I used the product for a few days and it did seem to work well but on the morning of (b)(6) around 1:30am while using the product according to the directions of the steam/water exploded causing the face mask to pop off the bottom steamer and burn my face.When i went to urgent care they treated me for second degree burns because of blistering and the depth of the burn to my face.Due to the burn being on my face and not wanting to cause permanent scarring i went to the dermatologist who also said the burn was a second degree and gave me ointments to keep it moisturized.You can imagine being (b)(6) pregnant and then getting second degree burns to my face did not create a strong emotional state.I had to miss my nephews first holy communion, my two nieces first holy communion and confirmations, one of whom i was a sponsor for as well as my nieces 8th grade promotion along with two weeks of work because i did not want to leave the house with the damage the burn caused to my face.My face has been healing but do have two remaining marks that are appearing darker than the rest of the area where the blisters were located that could leave permanent scars.

• Brand Name: WALGREENS PERSONAL WARM STEAM INHALER
• Type of Device: STEAM INHALER
• Manufacturer (Section D): BIGWALL ENTERPRISES; clarendon hills IL
• MDR Report Key: 4943424
• MDR Text Key: 6197109
• Report Number: 1460851-2015-00007
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 07/23/2015

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 Number: PJ1011
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Unknown
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/23/2015
• Distributor Facility Aware Date: 07/14/2015
• Event Location: Home
• Date Report to Manufacturer: 06/26/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/23/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other