MAUDE Adverse Event Report: UNKNOWN WALGREENS; PERSONAL STEAM INHALER

Model Number PJ1011

Device Problems Device Dislodged or Dislocated (2923); Noise, Audible (3273)

Patient Problem Burning Sensation (2146)

Event Date 02/27/2017

Event Type  Injury  

Event Description

After about a minute of inhaling the steam, customer heard a pop and felt something hit his face and felt a burning sensation - customer said he had used (b)(6) vaporizing steam liquid along with the steam inhaler.

• Brand Name: WALGREENS
• Type of Device: PERSONAL STEAM INHALER
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 6410069
• MDR Text Key: 70239844
• Report Number: MW5068482
• Device Sequence Number: 0
• Product Code: KFZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 02/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: PJ1011
• Device Catalogue Number: WIC366596
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/13/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1