MAUDE Adverse Event Report: AUGUSTINE TEMPERATURE MANAGEMENT HOT DOG WARMER / WARMING MATTRESS

Model Number WC52

Device Problem Insufficient Information (3190)

Patient Problems Erythema (1840); Partial thickness (Second Degree) Burn (2694)

Event Date 06/08/2016

Event Type  Injury  

Event Description

Pt reported to have 3 blisters on non-operative hip.Pt was lying on hot dog warmer device.Pt having total hip arthroplasty, duration approx 1.5 hours, when in pacu, pt complained of burning to non-operative hip.Softball sized reddened area with multiple blisters.

• Brand Name: HOT DOG WARMER / WARMING MATTRESS
• Type of Device: WARMER
• Manufacturer (Section D): AUGUSTINE TEMPERATURE MANAGEMENT; 6581 city west parkway; eden prairie MD 55344
• MDR Report Key: 5744475
• MDR Text Key: 48110123
• Report Number: MW5062982
• Device Sequence Number: 1
• Product Code: DWJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: WC52
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 97