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U.S. Department of Health and Human Services

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

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INTRAVASCULAR DEVICE; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
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).
 
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Brand Name
INTRAVASCULAR DEVICE
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
MDR Report Key15626572
MDR Text Key302022649
Report NumberMW5112704
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
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 Received10/17/2022
Patient Sequence Number1
Treatment
LIPITOR 10 MG/DAY; MRI MACHINE; MULTI VITAMIN
Patient Outcome(s) Required Intervention;
Patient Age68 YR
Patient SexFemale
Patient Weight77 KG
Patient EthnicityNon Hispanic
Patient RaceWhite
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