• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

3M COMPANY, 3M HEALTHCARE BAIR PAW WARMING GOWN SYSTEM, THERMAL, REGULATING Back to Search Results
Model Number 81003
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Inflammation (1932); Local Reaction (2035)
Event Date 05/22/2019
Event Type  Injury  
Event Description
Patient was in the operating room with a bair paw warming gown on. After the procedure. The patient's skin was observed to be reddened and blotchy to her neck and upper chest. Fda safety report id # (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBAIR PAW WARMING GOWN
Type of DeviceSYSTEM, THERMAL, REGULATING
Manufacturer (Section D)
3M COMPANY, 3M HEALTHCARE
MDR Report Key8658837
MDR Text Key146903478
Report NumberMW5087054
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? 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

-
-