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

Model Number PJ011

Device Problems Burst Container or Vessel (1074); Nonstandard Device (1420)

Patient Problem Burn, Thermal (2530)

Event Type  Injury  

Event Description

Consumer reported that her husband was using the product when the unit sputtered and caused hot water to burn the user's face.The user has not reported whether they sought medical attention.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
• MDR Report Key: 6315711
• MDR Text Key: 66940907
• Report Number: 1460851-2017-00003
• 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
• Type of Report: Initial
• Report Date: 02/09/2017

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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/09/2017
• Distributor Facility Aware Date: 01/11/2017
• Event Location: Home
• Date Report to Manufacturer: 01/11/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/09/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other