MAUDE Adverse Event Report: INTRAVASCULAR DEVICE; SET, ADMINISTRATION, INTRAVASCULAR

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Swelling/ Edema (4577)

Event Date 09/27/2022

Event Type  Injury  

Event Description

On (b)(6) 2022; i had an mri at (b)(6) hospital; i was given a drug called multihance (gadolinium) via iv injection into my left hand.The drug leeched out of my vein into my left hand.Later that day i was unable to use my hand, as it swelled to the size of a grapefruit; my fingers swelled also; since the mri that day, my hand is still swollen, and very painful.My primary care doctor recommended hot compresses for the swelling, but this drug has caused considerable pain and hardship for me.Fda safety report id# (b)(4).

• Brand Name: INTRAVASCULAR DEVICE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• MDR Report Key: 15626572
• MDR Text Key: 302022649
• Report Number: MW5112704
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/13/2022

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/17/2022
• Patient Sequence Number: 1
• Treatment: LIPITOR 10 MG/DAY; MRI MACHINE; MULTI VITAMIN
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White