• 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 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 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).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BAIR PAW WARMING GOWN
Type of Device
SYSTEM, 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
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/25/2019
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age69 YR
-
-