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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Rash (2033)
Event Date 12/14/2018
Event Type  Malfunction  
Event 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 NameBAIR HUGGER FLEX WARMING GOWN
Type of DeviceSYSTEM, THERMAL REGULATING
Manufacturer (Section D)
3M COMPANY
3m center, 2510 conway ave.
bldg. 275-5w-06
saint paul MN 55144
MDR Report Key8247977
MDR Text Key133113018
Report Number8247977
Device Sequence Number1
Product Code DWJ
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation RISK MANAGER
Type of Report Initial,Followup
Report Date 01/01/2019,12/31/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/15/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL Number81003
Device Catalogue Number81003
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2019
Event Location Hospital
Date Report TO Manufacturer01/15/2019
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? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 01/15/2019 Patient Sequence Number: 1
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