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

Model Number PJ011

Device Problems Burst Container or Vessel (1074); Device Operates Differently Than Expected (2913)

Patient Problem Injury (2348)

Event Date 10/09/2017

Event Type  Injury  

Event Description

Consumer reports that their (b)(6) child was using the warm steam personal inhaler and the inhaler malfunctioned wherein the stream shot up into the child's face and caused injuries that resulted in a visit to an emergency room for treatment.The product was discontinued for sale in (b)(6) as of (b)(6).The product was recalled (b)(6) and has not been sold in (b)(6) since that date.Ref (b)(4).

• Brand Name: WELL AT WALGREENS
• Type of Device: WARM STEAM PERSONAL INHALER
• Manufacturer (Section D): BIG WALL ENTERPRISES; 125 w 55th st.; ste 200; clarendon hills IL 60514 2301
• MDR Report Key: 7037479
• MDR Text Key: 92456137
• Report Number: MW5073382
• 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: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2017
• 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 Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other