MAUDE Adverse Event Report: MRI MACHINE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Abdominal Pain (1685); Fatigue (1849); Headache (1880); Itching Sensation (1943); Tachycardia (2095); Burning Sensation (2146); Urticaria (2278); Reaction, Injection Site (2442); Confusion/ Disorientation (2553); Alteration In Body Temperature (2682)

Event Date 01/11/2017

Event Type  Injury  

Event Description

Was administered gadolinium for a mri and upon injection into the vein, i had an immediate reaction that started with burning at the injection site.Then my head, scalp, and chest started itching which progressed to a burning sensation on my chest and back radiated down my arms to my pelvis and legs.Within a few minutes, my chest, neck, and back were covered in large hives.I was able to breathe although my heart rate was high (probably from the stress).I did have an immediate headache and my head felt extremely overheated.The doctors evaluated me and we determined that while my body was covered in hives i had the option to administer an epi-pen or use a large dose of benadryl.We opted to use the benadryl since my breathing was not labored.Within approximately one hour the hives subsided.My headache continued through the evening which i resolved with ibuprofen.The imaging staff stated the reaction is uncommon.It has been 12 hours since i was injected with the drug and thus far my only atypical symptoms are stomach ache and very tired with a fogginess.I do not appear to have any other symptoms.

• Brand Name: MRI MACHINE
• Type of Device: MRI MACHINE
• MDR Report Key: 6256221
• MDR Text Key: 65059930
• Report Number: MW5067242
• Device Sequence Number: 1
• Product Code: LNH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: EXERCISE INDUCED ASTHMA.; GENERAL VITAMINS INCLUDING IRON AND VITAMIN C.; OTC MEDS: BENEDRYL OCCASIONALLY; RX MEDS: ALBUTEROL FOR ALLERGY AND; SEASONAL ALLERGY MEDS
• Patient Outcome(s): Other
• Patient Age: 44 YR
• Patient Weight: 101