MAUDE Adverse Event Report: WALGREENS; PERSONAL STEAM INHALER

Device Problem Burst Container or Vessel (1074)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/01/2017

Event Type  Injury  

Event Description

Customer was using steam inhaler one day and it popped.Was using it for a cold and so was using the vaporizing steam liquid with it.This is what the (b)(6) store employees told him to use with it.

• Brand Name: WALGREENS
• Type of Device: PERSONAL STEAM INHALER
• MDR Report Key: 6446322
• MDR Text Key: 71394028
• Report Number: MW5068745
• Device Sequence Number: 1
• Product Code: KCO
• 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: 03/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 03/28/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 43 YR