MAUDE Adverse Event Report: BIGWALL ENTERPRISES WELL AT WALGREENS; PERSONAL STEAM INHALER

Model Number PJ1011

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Burn(s) (1757)

Event Type  Injury  

Event Description

User reported using the steam inhaler with face mask adaptor with an added vapor solution.According to the user, the user sustained burns to her face when using the unit.This product was recalled from stores in (b)(6) 2015.Unit instructions state that users should "not use additives" and to "use water only".The product supplier, (b)(4), submitted an adverse event report on (b)(6) 2016 (report # (b)(4)).

• Brand Name: WELL AT WALGREENS
• Type of Device: PERSONAL STEAM INHALER
• Manufacturer (Section D): BIGWALL ENTERPRISES; 125 w. 55th st.; suite 200; clarendon hills IL 60514
• MDR Report Key: 5869610
• MDR Text Key: 51922445
• Report Number: 1460851-2016-00004
• Device Sequence Number: 1
• Product Code: KFZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: PJ1011
• Device Catalogue Number: 366596
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/11/2016
• Distributor Facility Aware Date: 07/15/2016
• Event Location: Home
• Date Report to Manufacturer: 08/11/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 79 YR