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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 REGULATING

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3M COMPANY, 3M HEALTH CARE BAIR PAW WARMING GOWN SYSTEM, THERMAL REGULATING Back to Search Results
Model Number 81003
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem Erythema (1840)
Event Date 05/30/2019
Event Type  Injury  
Event Description
Pt was noted to have red blotchy areas on their upper chest and arms following a surgical procedure. Anesthesia reports the blower was on medium and a bath blanket was not being used. 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 HEALTH CARE
MDR Report Key8683030
MDR Text Key147507222
Report NumberMW5087202
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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