MAUDE Adverse Event Report: UNKNOWN FEEDING TUBE; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

Spontaneous.Rph (b)(6) at (b)(6) hospital reports pt was admitted today (b)(6) 2023 due to a feeding tube malfunction (onset date unknown).Author notified md.No further info, details or dates available.Sq remodulin ms3 pt.Reported to (b)(6) by: health professional.

• Brand Name: FEEDING TUBE
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 18240331
• MDR Text Key: 329481175
• Report Number: MW5148610
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• 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: 11/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: NAME: C-AMBRISENTAN SUSP.STRENGTH: 1MG/ML.MANUFACTURER: CIPLA USA.; REMODULIN MDV.
• Patient Outcome(s): Hospitalization
• Patient Sex: Male