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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYRINGE, PISTON

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SYRINGE, PISTON Back to Search Results
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.
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MDR Report Key12975631
MDR Text Key282102532
Report NumberMW5105941
Device Sequence Number1
Product Code FMF
Combination Product (y/n)Y
Number of Events Reported1
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 Received12/09/2021
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