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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: 3M COMPANY, 3M HEALTHCARE BAIR PAW WARMING GOWN; SYSTEM THERMAL REGULATING

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3M COMPANY, 3M HEALTHCARE BAIR PAW WARMING GOWN; SYSTEM THERMAL REGULATING Back to Search Results
Model Number 81003
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Skin Discoloration (2074)
Event Date 05/16/2019
Event Type  Injury  
Event Description
Patient was in the operating room for procedure with the bair paw warming gown on.The arms extended to the sides and warmer was completely inflated without any obstructions.Temp on high and flow on low watt.The physician evaluated the patient and noted chest and both arms were discolored, and her face was flushed.The warmer was discontinued at that time.Fda safety report id # (b)(4).
 
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Brand Name
BAIR PAW WARMING GOWN
Type of Device
SYSTEM THERMAL REGULATING
Manufacturer (Section D)
3M COMPANY, 3M HEALTHCARE
MDR Report Key8658724
MDR Text Key146833846
Report NumberMW5087051
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 Nurse
Type of Report Initial
Report Date 05/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number81003
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/30/2019
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age36 YR
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