MAUDE Adverse Event Report: AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.) AVANOS CLOTEST; HELICOBACTER PYLORI

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Other  

Event Description

Avanos clotest being sold to hospitals as an fda approved waived test.It is not located on the fda accessdata website.Hospitals are utilizing this test kit thinking they are using an fda approved kit when in actuality they are not and could be cited by clia (cms) for utilizing an unapproved test.Not fda approved; not classified on the fda website for complexity.Being sold to hospitals saying they are fda approved and have been determined to be waived.

• Brand Name: AVANOS CLOTEST
• Type of Device: HELICOBACTER PYLORI
• Manufacturer (Section D): AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.)
• MDR Report Key: 17624345
• MDR Text Key: 322136741
• Report Number: MW5144957
• Device Sequence Number: 1
• Product Code: LYR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1