MAUDE Adverse Event Report: BIGWALL ENTERPRISES WELL AT WALGREENS; STEAM INHALER

Model Number PJ1011

Device Problems Burst Container or Vessel (1074); Nonstandard Device (1420)

Patient Problems Loss of Vision (2139); Partial thickness (Second Degree) Burn (2694); Full thickness (Third Degree) Burn (2696)

Event Date 02/06/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Per the complaint supplied below, consumer alleged that the steam inhaler blew up causing third degree facial burns.This complaint has been provided to the supplier for investigation.The product was recalled from (b)(6) stores in (b)(6).Supplier for this product to (b)(6) is bigwall enterprises.Consumer statement: my mom is (b)(6) years old and she used this steam inhaler and it blew up in her face and gave her 3rd degree burns.She has burns on the insides of her eyes and blisters on her nose.I took it back to the store and (b)(6) told me that they had already been pulled and recalled and she told me to call you.My mom has burns on her nose and under her eyes and scabs are forming.She also has some vision loss in her eye, and it's too early to tell if this is permanent.

• Brand Name: WELL AT WALGREENS
• Type of Device: STEAM INHALER
• Manufacturer (Section D): BIGWALL ENTERPRISES; 125 w. 55th st.; suite 200; clarendon hills IL 60514
• MDR Report Key: 5742298
• MDR Text Key: 47964249
• Report Number: 1460851-2016-00001
• Device Sequence Number: 1
• Product Code: KFZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: PJ1011
• Device Catalogue Number: 366596
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/04/2016
• Distributor Facility Aware Date: 02/06/2016
• Event Location: Home
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR