MAUDE Adverse Event Report: POVOS WALGREENS PERSONAL WARM STEAM INHALER

Model Number PJ1011

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Date 03/11/2015

Event Type  Injury  

Event Description

According to a complaint forwarded to walgreens by the product supplier, (b)(4), the consumer sustained burns to her face, lips, and chin area while using this product (b)(4).The product named in this complaint is the walgreens personal steam inhaler (walgreens wic (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: 4795517
• MDR Text Key: 5878223
• Report Number: 1460851-2015-00002
• Device Sequence Number: 1
• Product Code: KCO
• 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

• 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
• Date Report to Manufacturer: 05/22/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/22/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 78 YR