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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: 3M COMPANY BAIR HUGGER SYSTEM, THERMAL REGULATING

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3M COMPANY BAIR HUGGER SYSTEM, THERMAL REGULATING Back to Search Results
Model Number 775
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Rash (2033); Sweating (2444); Burn, Thermal (2530)
Event Date 03/04/2020
Event Type  malfunction  
Event Description
Patient diaphoretic and flushed. Operating room rn stated the bair hugger was on the patient. Patient also noted to have a patterned red rash or burn on her inner left thigh believed to be from the use of the bair hugger.
 
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Brand NameBAIR HUGGER
Type of DeviceSYSTEM, THERMAL REGULATING
Manufacturer (Section D)
3M COMPANY
3m center, 2510 conway ave
bldg. 275-5w-06 MN 55144
MDR Report Key10118197
MDR Text Key193974885
Report Number10118197
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 Other Health Care Professional
Type of Report Initial
Report Date 05/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number775
Device Catalogue Number77500
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/21/2020
Event Location Hospital
Date Report to Manufacturer06/04/2020
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: 06/04/2020 Patient Sequence Number: 1
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