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U.S. Department of Health and Human Services

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

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3M COMPANY BAIR PAW WARMING GOWN SYSTEM, THERMAL REGULATING Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Rash (2033)
Event Date 07/26/2019
Event Type  malfunction  
Event Description
Post procedure, the bair paw warming gown was removed from the pt and they were noted to have red rash to bilateral upper arms and on their chest. The redness was only present where the warming gown came in contact with the pt. 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
MDR Report Key9244567
MDR Text Key164122729
Report NumberMW5090672
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 Risk Manager
Type of Report Initial
Report Date 10/23/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/25/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
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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