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

MAUDE Adverse Event Report: AVANOS MEDICAL, INC. AVANOS ANESTHESIA CONDUCTION KIT

  • 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
 

AVANOS MEDICAL, INC. AVANOS ANESTHESIA CONDUCTION KIT Back to Search Results
Model Number 181A321
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/20/2022
Event Type  malfunction  
Event Description
All avanos universal block trays missing 1-lbl for nkt products. All of lot 30175885 affected.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameAVANOS
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
AVANOS MEDICAL, INC.
5405 windward parkway
alpharetta GA 30004
MDR Report Key14287856
MDR Text Key290782061
Report Number14287856
Device Sequence Number1
Product Code CAZ
UDI-Device Identifier00193493997947
UDI-Public(01)00193493997947(240)109979402(17)30175885
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 04/20/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/05/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number181A321
Device Catalogue Number181A321
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/20/2022
Event Location Hospital
Date Report to Manufacturer05/05/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-