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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN WARMTOUCH SYSTEM, THERMAL REGULATING

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COVIDIEN WARMTOUCH SYSTEM, THERMAL REGULATING Back to Search Results
Model Number 5030810
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Rash (2033)
Event Date 02/06/2018
Event Type  malfunction  
Event Description
The patient reported that she had a rash under her breasts, from her breast to her under arm and her mid thighs. The conclusion was that the rash may have been caused by the warming blanket placed on her prior to surgery. Operating room (or) manager emailed the product information to her so that she could determine what she may be allergic to.
 
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Brand NameWARMTOUCH
Type of DeviceSYSTEM, THERMAL REGULATING
Manufacturer (Section D)
COVIDIEN
15 hampshire st.
mansfield MA 02048
MDR Report Key7258798
MDR Text Key99545840
Report Number7258798
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 02/08/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/09/2018
Is this a Product Problem Report? Yes
Device Operator
Device Model Number5030810
Device Catalogue Number5030810
Other Device ID NumberFULL BODY/MULTI ACCESS BLANKE
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/08/2018
Event Location Hospital
Date Report to Manufacturer02/08/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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