MAUDE Adverse Event Report: POVOS WALGREENS PERSONAL INHALER

Model Number PJ1011

Device Problem Burst Container or Vessel (1074)

Patient Problem Injury (2348)

Event Date 12/18/2016

Event Type  Injury  

Event Description

I was preheating the water and getting ready to start inhaling the steam.When the entire unit popped into the air, blowing the clear vinyl piece across the room and sent boiling water all over my neck and chest.(b)(6).

• Brand Name: WALGREENS PERSONAL INHALER
• Type of Device: PERSONAL INHALER
• Manufacturer (Section D): POVOS
• MDR Report Key: 6194386
• MDR Text Key: 62983429
• Report Number: MW5066831
• Device Sequence Number: 1
• Product Code: CAF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• 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: 12/20/2016
• 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?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR
• Patient Weight: 86