MAUDE Adverse Event Report: BIG WALL ENTERPRISES WELL AT WALGREENS; WARM STEAM PERSONAL INHALER

Model Number PJ011

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Burn(s) (1757)

Event Date 02/03/2017

Event Type  Injury  

Event Description

Consumer reports that she has used the product for 10 to 11 months without issue, but on (b)(6) 2017, she noticed that the water was bubbling in the device.Shortly thereafter water shot up from the device and burned her forehead.Consumer sought medical attention and reports that the burns were either first or second degree.This product was recalled in november 2015 and has not been sold at (b)(6) since that time.

• Brand Name: WELL AT WALGREENS
• Type of Device: WARM STEAM PERSONAL INHALER
• Manufacturer (Section D): BIG WALL ENTERPRISES; 125 w 55th st; suite 200; clarendon hills IL 60514 2301
• MDR Report Key: 6341503
• MDR Text Key: 67830707
• Report Number: 1460851-2017-00004
• Device Sequence Number: 1
• Product Code: KFZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/17/2017

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: PJ011
• Device Catalogue Number: 366596
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/17/2017
• Distributor Facility Aware Date: 02/03/2017
• Event Location: Home
• Date Report to Manufacturer: 02/07/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/17/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other