MAUDE Adverse Event Report: WALGREENS/BIG WALL ENTERPRISES WALGREENS PERSONAL STEAM INHALER

Device Problem Burst Container or Vessel (1074)

Patient Problem Burn, Thermal (2530)

Event Date 12/30/2016

Event Type  Injury  

Event Description

There was an explosion of the unit, customer was scorched by hot steam.

• Brand Name: WALGREENS PERSONAL STEAM INHALER
• Type of Device: PERSONAL STEAM INHALER
• Manufacturer (Section D): WALGREENS/BIG WALL ENTERPRISES ; 5151 beltline rd.; ste 878; dallas TX 75254
• MDR Report Key: 6600853
• MDR Text Key: 76401259
• Report Number: MW5070081
• 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: Unknown
• Type of Report: Initial
• Report Date: 05/17/2017

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: No Information
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/26/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1