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

Device Problem Data Problem (3196)

Patient Problem Insufficient Information (4580)

Event Date 05/17/2021

Event Type  malfunction  

Event Description

Lab test system; avanos clotest rapid urease test being marketed as a waived test - hospitals utilizing as a waived test - cannot find the test in the clia/fda database - i do have a copy of the package insert (instructions for use).Fda safety report id # (b)(4).

• Brand Name: AVANOS CLOTEST RAPID UREASE TEST SYSTEM
• Type of Device: HELICOBACTER PYLORI
• Manufacturer (Section D): AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.)
• MDR Report Key: 11854849
• MDR Text Key: 252158488
• Report Number: MW5101438
• Device Sequence Number: 1
• Product Code: LYR
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other