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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: 3M COMPANY WARMER, PATIENT SYSTEM, THERMAL REGULATING

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3M COMPANY WARMER, PATIENT SYSTEM, THERMAL REGULATING Back to Search Results
Model Number BAIR HUGGER 675
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Erythema (1840)
Event Date 09/23/2021
Event Type  Injury  
Event Description
Bair hugger placed on patient for duration of procedure. Upon procedure completion, bair hugger blanket was removed and widespread erythema noted to patient skin. Biomed contacted for machine testing. Pacu rn notified and patient monitored. Erythema had subsided by 1030am, and patient reports no discomfort. Fda safety report id# (b)(4).
 
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Brand NameWARMER, PATIENT
Type of DeviceSYSTEM, THERMAL REGULATING
Manufacturer (Section D)
3M COMPANY
MDR Report Key12893577
MDR Text Key281524458
Report NumberMW5105663
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 Voluntary
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 11/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberBAIR HUGGER 675
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 11/29/2021 Patient Sequence Number: 1
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