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U.S. Department of Health and Human Services

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

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AUGUSTINE TEMPERATURE MANAGEMENT HOT DOG WARMER/ WARMING MATTRESS Back to Search Results
Model Number WC52
Device Problem Insufficient Information (3190)
Patient Problems Erythema (1840); Burning Sensation (2146); 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 approximately 1. 5 hours, when in pacu, pt complained of burning to non-operative hip. Softball sized reddened area with multiple blisters.
 
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Brand NameHOT DOG WARMER/ WARMING MATTRESS
Type of DeviceHOT DOG WARMER/ WARMING MATTRESS
Manufacturer (Section D)
AUGUSTINE TEMPERATURE MANAGEMENT
6581 city west parkway
eden prairie MD 55344
MDR Report Key5747807
MDR Text Key48202174
Report NumberMW5062994
Device Sequence Number1
Product Code DWJ
Reporter Country CodeUS
Number of Events Reported1
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 Received06/21/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberWC52
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

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