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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: 3M BAIR HUGGER

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3M BAIR HUGGER Back to Search Results
Model Number 775
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Skin Discoloration (2074); Partial thickness (Second Degree) Burn (2694)
Event Date 11/07/2016
Event Type  Injury  
Event Description
Child developed a large 14cm x 9cm reddened area to left flank/back that on post-op day 2 started blistering/sloughing, consistent with a burn injury. (b)(6) old male with ingestion of foreign bodies taken to operating room for an exploratory laparotomy with partial small bowel resection with closure of enterotomy. A pediatric underbody bair hugger that was used during the case. Anesthesia start time of 0223 and end time of 0504. The device was utilized upon initiation of the case and use was discontinued at 0355 as the pt's temperature was 37. 8 and no longer required this device. Upon completion of the case and transfer to the pacu, the child was noted to have a 14cm x 9cm reddened area to left flank/back that was not noted to be present prior to the case. Throughout the morning, the area became darker and appeared tender. On post-op day 2, the wound began to blister and slough skin, consistent with a burn. Upon further investigation, the device was utilized as per the mfr's recommendations. There were no alarms received by the device indicating the device temperature was too high. The device was removed from service and our biomed department evaluated the equipment and found no issues. All bair hugger devices at this facility have recently been upgraded and of note 3 of our other bair hugger devices have been alarming high temperature and have also been removed from service. The concerns have been reported to the mfr and they are currently investigating.
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Type of DeviceBAIR HUGGER
Manufacturer (Section D)
MDR Report Key6112629
MDR Text Key60565851
Report NumberMW5066097
Device Sequence Number1
Product Code DWJ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 11/16/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number775
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
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?
Type of Device Usage

Patient Treatment Data
Date Received: 11/16/2016 Patient Sequence Number: 1