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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: 3M COMPANY BAIR HUGGER FLEX WARMING GOWN; SYSTEM, THERMAL REGULATING
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3M COMPANY BAIR HUGGER FLEX WARMING GOWN; SYSTEM, THERMAL REGULATING Back to Search Results
Model Number 81003
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Rash (2033)
Date of Event 12/14/2018
Type of Reportable Event Malfunction
Event or Problem Description
Patient has small dot rash over bair hugger area on chest.No itching or welts, or pain noted this has been a recurring event over the last few weeks.Bair hugger gowns have been used for years.
 
Event or Problem Description
Patient has small dot rash over bair hugger area on chest.No itching or welts, or pain noted this has been a recurring event over the last few weeks.Bair hugger gowns have been used for years.
 
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Brand Name
BAIR HUGGER FLEX WARMING GOWN
Common Device Name
SYSTEM, THERMAL REGULATING
Manufacturer (Section D)
3M COMPANY
3m center, 2510 conway ave.
bldg. 275-5w-06
saint paul MN 55144
MDR Report Key8247977
Report Number8247977
Device Sequence Number1437355
Product Code DWJ
Combination Product (Y/N)N
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type User Facility
Type of Report Initial,Followup
Report Date (Section B) 12/31/2018
Report Date (Section F) 01/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device No Information
Device Model Number81003
Device Catalogue Number81003
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Event Location Hospital
Date Report to Manufacturer01/15/2019
Initial Date Received by Manufacturer Not provided
Supplement Date Received by ManufacturerNot provided
Initial Report FDA Received Date01/15/2019
Supplement Report FDA Received Date01/29/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Date Report Sent to FDA01/01/2019
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