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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 Problem Rash (2033)
Event Date 06/03/2019
Event Type  Injury  
Event Description
Pt was noted to have a "heat rash" on their chest while using the bair paw warming gown. Fda safety report id# (b)(4).
 
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Brand NameBAIR PAW WARMING GOWN
Type of DeviceSYSTEM, THERMAL REGULATING
Manufacturer (Section D)
3M COMPANY/ 3M HEALTHCARE
MDR Report Key8682967
MDR Text Key147559661
Report NumberMW5087201
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
0 Patients were 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

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