MAUDE Adverse Event Report: SHANGHAI POVOS ELECTRIC WORKS WALGREENS PERSONAL INHALER

Model Number PJ1011

Device Problem Burst Container or Vessel (1074)

Patient Problem Burn(s) (1757)

Event Date 12/18/2016

Event Type  Injury  

Event Description

Customer was preheating the water and getting ready to start inhaling the steam.When the entire unit popped into the air, blowing the clean vinyl piece across the room and sent boiling water all over her neck and chest.

• Brand Name: WALGREENS PERSONAL INHALER
• Type of Device: PERSONAL INHALER
• Manufacturer (Section D): SHANGHAI POVOS ELECTRIC WORKS; 249 rongping rd.; songjiang qu, shanghai shi 20161 3; CH 201613
• MDR Report Key: 6279479
• MDR Text Key: 65848264
• Report Number: MW5067489
• Device Sequence Number: 1
• Product Code: KFZ
• 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: 12/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: PJ1011
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other