MAUDE Adverse Event Report: UNKNOWN SET, ADMINISTRATION, INTRAVASCULAR

Patient Problems Pain (1994); Hot Flashes/Flushes (2153); Unspecified Respiratory Problem (4464)

Event Type  Injury  

Event Description

Date of last site change: (b)(6) 2023.Pt reports their site was leaking and therefore they were not getting exact dose of remodulin and had to be hospitalized (admitted (b)(6) 2023 and discharged (b)(6) 2023; md aware).Pt was on iv remodulin while hospitalized and was experiencing jaw pain, flushing, and other unspecified side effects related to iv remodulin.Pt reports adverse events are better but still lingering.Pt states that since their hospitalization their breathing has slightly worsened but is improving (not 100% yet).Unknown if md is aware of all events.No further info, details or dates available.Md phone number: (b)(6).Sq remunity self-fill pt.Pt started using remunitv device (b)(6) 2023.Reported to (b)(6) by: patient/caregiver.

• Brand Name: SET, ADMINISTRATION, INTRAVASCULAR
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 18365729
• MDR Text Key: 331085636
• Report Number: MW5149416
• Device Sequence Number: 1
• Product Code: FPA
• 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: 12/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• 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: ADEMPAS.; REMODULIN MDV.
• Patient Outcome(s): Hospitalization
• Patient Sex: Female