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

0 Patients were 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

• Device Model Number: WC52
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No Answer Provided

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage