MAUDE Adverse Event Report: POVOS WALGREENS PERSONAL WARM STEAM INHALER

Model Number PJ1011

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Burn(s) (1757)

Event Type  Injury  

Event Description

According to the supplier, (b)(6), the consumer claims that the facial adapter fell off the steam inhaler causing hot water to pour on to her lap.She alleges that this caused her to sustain burns to her thigh and buttocks region.(see (b)(4)).The product named in this complaint is the walgreens 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: 4795538
• MDR Text Key: 16992252
• Report Number: 1460851-2015-00006
• 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: 05/12/2015
• Event Location: Home
• Date Report to Manufacturer: 05/22/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1