MAUDE Adverse Event Report: SHANGHAI POVOS WALGREENS WARM STEAM PERSONAL STEAM INHALER

Model Number PJ1011

Device Problems Burst Container or Vessel (1074); Material Integrity Problem (2978)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 10/31/2015

Event Type  Injury  

Event Description

Customer used the walgreen co.Warm steam personal steam inhaler for the first time on (b)(6) 2015 for a few minutes without incident.On (b)(6) 2015, plugged in inhaler, turned on and nothing happened.Turned off and then turned on again, was heating up (3-4 minutes), and then while using the facial attachment for less than a minute, scalding hot water and steam exploded into her face causing second degree burns to her face (cheeks, lips, nose, chin and eyes).Went to the emergency room and received follow up care with plastic surgeon and eye doctor.Manufacturer: (b)(4).Device model no: pj1011.

• Brand Name: WALGREENS WARM STEAM PERSONAL STEAM INHALER
• Type of Device: WALGREENS WARM STEAM PERSONAL STEAM INHALER
• Manufacturer (Section D): SHANGHAI POVOS
• MDR Report Key: 5396697
• MDR Text Key: 37041310
• Report Number: MW5059709
• 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: Other
• Type of Report: Initial
• Report Date: 10/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: PJ1011
• Device Lot Number: 366596
• Other Device ID Number: 3 11917 17008 4
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: RX MEDS: LEXAPRO
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 64