MAUDE Adverse Event Report: SYRINGE, PISTON

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Renal Failure (2041); Multiple Organ Failure (3261)

Event Type  Injury  

Event Description

Spontaneous call. Spoke with patient during orenitram consult. Patient stated that she was not doing well after receiving her booster of covid-19 pfizer vaccine on (b)(6) 2021. As a result, she was in the hospital from (b)(6) 2021 to (b)(6) 2021 due to kidney failure and issues with her organs shutting down. She was not able to take the orenitram while in the hospital. She had to restart the medication and titrate at a slower rate due to inflammation in the stomach. Current dose is 1. 5mg by mouth three times daily. Her doctor is aware of the situation. There is no other information known. Reported to (b)(6) by pt/caregiver.

• Brand Name: SYRINGE, PISTON
• Type of Device: SYRINGE, PISTON
• MDR Report Key: 12975631
• MDR Text Key: 282102532
• Report Number: MW5105941
• Device Sequence Number: 1
• Product Code: FMF
• 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: 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: Yes

Patient Treatment Data

Date Received: 12/09/2021 Patient Sequence Number: 1