MAUDE Adverse Event Report: UNKNOWN INTRAVENOUS PORT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

Spontaneous communication received from lancet., pharmacist at (b)(6) to report patient is admitted to the hospital due to her intravenous port is leaking and patient is having a procedure to replace her intravenous line.No additional information provided.Date of admission or anticipated discharge date not provided.Length of stay is ongoing.Unknown if md is aware.Iv remodulin patient.Reported to (b)(6) by: health professional.

• Brand Name: INTRAVENOUS PORT
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 18257779
• MDR Text Key: 329726751
• Report Number: MW5148712
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): Y
• 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: 11/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/01/2023
• Patient Sequence Number: 1
• Treatment: AMBRISENTAN.; TADALAFIL.
• Patient Outcome(s): Hospitalization
• Patient Sex: Female