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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, REGUALTING

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3M COMPANY, 3M HEALTHCARE BAIR PAW WARMING GOWN SYSTEM, THERMAL, REGUALTING Back to Search Results
Model Number 81003
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Local Reaction (2035); Skin Inflammation (2443)
Event Date 05/21/2019
Event Type  Injury  
Event Description
Patient was in the operating room with the bair paw warming gown on. Once the warming gown was removed, red blotchy areas were noted on the patient's chest and upper arms. Fda safety report id # (b)(4).
 
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Brand NameBAIR PAW WARMING GOWN
Type of DeviceSYSTEM, THERMAL, REGUALTING
Manufacturer (Section D)
3M COMPANY, 3M HEALTHCARE
MDR Report Key8658708
MDR Text Key146847304
Report NumberMW5087050
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 05/28/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/30/2019
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? 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? No
Type of Device Usage

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