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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: 3M COMPANY, 3M HEALTH CARE BAIR PAW WARMING GOWN SYSTEM, THERMAL REGULATOR

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3M COMPANY, 3M HEALTH CARE BAIR PAW WARMING GOWN SYSTEM, THERMAL REGULATOR Back to Search Results
Model Number 81003
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Erythema (1840)
Event Date 05/30/2019
Event Type  Injury  
Event Description
Pt was noted to have redness and blotchy areas to their upper torso and arms from the bair paw warming gown. Anesthesia reports the blower was on medium and a bath blanket was not applied over the gown. Fda safety report id# (b)(4).
 
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Brand NameBAIR PAW WARMING GOWN
Type of DeviceSYSTEM, THERMAL REGULATOR
Manufacturer (Section D)
3M COMPANY, 3M HEALTH CARE
MDR Report Key8683066
MDR Text Key147523674
Report NumberMW5087204
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
Type of Report Initial
Report Date 06/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/07/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number81003
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
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? No
Type of Device Usage

Patient Treatment Data
Date Received: 06/07/2019 Patient Sequence Number: 1
Treatment
PROPOFOL
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