MAUDE Adverse Event Report: POVOS WALGREENS PERSONAL WARM STEAM INHALER

Model Number PJ1011

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Burn(s) (1757)

Event Type  Injury  

Event Description

A complaint was provided to (b)(6) on (b)(6) 2015 alleging that hot water spilled out of a steam inhaler and burned her son.The complaint was provided, in (b)(6) 2015, to the supplier big wall enterprises, who attempted to follow-up with the complainant.According to (b)(6) , the company has tried to contact the consumer numerous times through the contact information provided by the consumer to verify the allegations in the complaint.No further information is available regarding this complaint.Despite not being able to verify the allegations in this complaint, (b)(6) has determined that this event should be reported to fda due to presence of other adverse event complaints that it has recently been made aware of.The product named in this complaint is the (b)(6) personal steam inhaler (b)(4).

• Brand Name: WALGREENS PERSONAL WARM STEAM INHALER
• Type of Device: STEAM INHALER
• Manufacturer (Section D): POVOS; shanghai ; CH
• Manufacturer (Section G): WALGREEN CO.; 200 wilmot rd.; deerfield IL 60015
• Manufacturer Contact: 200 wilmot rd.; deerfield, IL 60015
• MDR Report Key: 4795537
• MDR Text Key: 5855953
• Report Number: 1460851-2015-00005
• Device Sequence Number: 1
• Product Code: CAF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2015
• 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?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/22/2015
• Distributor Facility Aware Date: 02/23/2015
• Event Location: Home
• Date Report to Manufacturer: 05/22/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1