MAUDE Adverse Event Report: AVANOS, MEDICAL, INC. CORTRAK ; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number STOCK CODE 20-0959

Device Problem Positioning Problem (3009)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/28/2020

Event Type  No Answer Provided  

Event Description

The product should clearly state contraindications for insertion.Fda safety report id# (b)(4).

• Brand Name: CORTRAK
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): AVANOS, MEDICAL, INC.
• MDR Report Key: 9694974
• MDR Text Key: 179110137
• Report Number: MW5092923
• Device Sequence Number: 2
• Product Code: KNT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 02/06/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: STOCK CODE 20-0959
• Device Lot Number: SRU 1210029
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/10/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1