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U.S. Department of Health and Human Services

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

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3M COMPANY BAIR HUGGER BLANKET SYSTEM, THERMAL REGULATING Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Itching Sensation (1943); Rash (2033); Skin Irritation (2076); Swelling (2091)
Event Date 11/14/2019
Event Type  Injury  
Event Description
Pt called to report adverse event involving the bair hugger warming blanket. Pt stated the device was used on her when she was in the hosp for shoulder surgery. Pt stated she did not ask for the device to be used but was assured it was safe and would help keep her warm. Pt said after her surgery, she developed a rash all over her body. Pt stated her rash has become worse and she is in agony, suffering from the itchy, pustular blisters. Pt said they look like cuts on her skin. Pt was recently put on antibiotics but is concerned about developing infections. Pt believes the material that the device is made of contains something harmful to her skin.
 
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Brand NameBAIR HUGGER BLANKET
Type of DeviceSYSTEM, THERMAL REGULATING
Manufacturer (Section D)
3M COMPANY
MDR Report Key9349216
MDR Text Key167388642
Report NumberMW5091199
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 Patient
Type of Report Initial
Report Date 11/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 11/19/2019 Patient Sequence Number: 1
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