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

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

Spontaneous.Rn (b)(6) from md office reports pt was hospitalized today (b)(6) 2023 for an unspecified g-tube issue (onset date unknown).No further info, details or dates available.Sq remodulin ms3 pt.Reported to (b)(6) by: health professional.

• Brand Name: G-TUBE
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17926041
• MDR Text Key: 325734583
• Report Number: MW5146891
• 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: 10/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2023
• 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