MAUDE Adverse Event Report: ULTRASOUND; MEDIA, COUPLING, ULTRASOUND

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Itching Sensation (1943); Rash (2033)

Event Date 04/08/2001

Event Type  Injury  

Event Description

A day or two before i reported this problem to the doctor around april 8, i was getting an ultrasound of my heart done.I had a terrible reaction to the ultra sound gel they used.I have never had this kind of problem before and i believe it was the gel.The rash appeared the next day after the ultrasound it was over half my chest red itchy and hot.I waited a day to see if it would go away, and when it didn't i reported it to the doctor because it was unbearable.I was given a steroid and an antibiotic to get it back under control, i can't remember which.After taking the prescribed medicine, it cleared but i read about the recall of ultrasound gels and thought i should report this because this was a miserable experience for me and i think the gel was the cause.I have a picture of the incident along with the doctors office where i reported it should you require more evidence.The office where this incident occurred was radiant heart and vascular care.Dr (b)(6).Fda safety report id # (b)(4).

• Brand Name: ULTRASOUND
• Type of Device: MEDIA, COUPLING, ULTRASOUND
• MDR Report Key: 12917025
• MDR Text Key: 281690072
• Report Number: MW5105735
• Device Sequence Number: 1
• Product Code: MUI
• Combination Product (y/n): N
• 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: 11/29/2021

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: 12/01/2021
• Patient Sequence Number: 1
• Treatment: ALBUTEROL ; ASPIRIN 81 MG; ATORVASTATIN ; BRILINTA; BYSTOLIC; GLIPIZIDE ; LOSARTAN ; OXYGEN ; REPATHA; SYMBICORT
• Patient Outcome(s): Other
• Patient Age: 42 YR
• Patient Sex: Male
• Patient Weight: 136 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White