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U.S. Department of Health and Human Services

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

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3M COMPANY BAIR HUGGER WARMING SYSTEM SYSTEM, THERMAL REGULATING Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Bacterial Infection (1735)
Event Date 11/10/2010
Event Type  Injury  
Event Description
The date reported and any periods of time listed are all approximate. I had my right knee replaced. My attorney told me that my medical records indicate the bair hugger warming system was used during the operation. Three weeks later, i got (b)(6) in my knee and was placed in the hospital for about 10 days. I was on strong iv antibiotics for another 6 months at home and had recement in my knee during that period of time, until the infection cleared up. Another operation was done to replace the knee. Prior to the first operation, a nasal swab was done and (b)(6) was detected. Since i had (b)(6) before the original operation, the attorney said i have no legal case against the bair hugger system mfr but that i should report this case to your organization.
 
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Brand NameBAIR HUGGER WARMING SYSTEM
Type of DeviceSYSTEM, THERMAL REGULATING
Manufacturer (Section D)
3M COMPANY
MDR Report Key7978674
MDR Text Key124352648
Report NumberMW5080622
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 10/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/17/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
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: 10/17/2018 Patient Sequence Number: 1
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