MAUDE Adverse Event Report: POVOS WALGREENS PERSONAL WARM STEAM INHALER

Model Number PJ1011

Device Problem Device Slipped (1584)

Patient Problem Burn(s) (1757)

Event Date 02/13/2015

Event Type  Injury  

Event Description

The customer reported having used the item for four days.On the fourth day, the customer reported that water came out of the machine and caused burns to his face and eye.A report of this incident was initially made in (b)(6) 2015 to the insurance company that handles claims for walgreens.Walgreens legal was made aware of this event on may 8, 2015 and determined that a report should be made to fda.The supplier, (b)(4), has been made aware of this event and is in the process of investigating.(b)(4) previously sent a report to fda regarding this incident (see (b)(4)).The product named in this complaint is the walgreens personal steam inhaler (walgreens (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: 4795518
• MDR Text Key: 5833588
• Report Number: 1460851-2015-00003
• 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: 05/08/2015
• Event Location: Home
• Date Report to Manufacturer: 05/22/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1