MAUDE Adverse Event Report: ULTRASOUND GEL; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Device Problem Use of Device Problem (1670)

Patient Problems Abdominal Pain (1685); Fatigue (1849); Headache (1880); Hypersensitivity/Allergic reaction (1907); Pain (1994); Vomiting (2144); Dizziness (2194); Ambulation Difficulties (2544); Confusion/ Disorientation (2553)

Event Date 07/08/2020

Event Type  Injury  

Event Description

I was at the (b)(6) medical center emergency department with severe stomach pains.I was taken to get an ultrasound of my abdomen.Before they wheeled me out, i had become blind.I told the nurse something was wrong.She said it couldn't be the ultrasound gel because all it contained was water.Thank god as the day went on my vision returned but had a splitting headache and felt queasy and disoriented.I later looked it up to learn the ultrasound gel contains water - and polyethylene glycol.I started thinking about how sick i became, the few times i used my estrogen suppository.Severe fatigue, dull pain throughout my body.I called the pharmacist to ask if the suppository contained peg.She said no.Ten minutes later she called me back and said yes it did.She confirmed that yes i do have an allergy to peg.On another occasion i was at a high-end spa getting a massage.The therapist suggested i try the fub balm for energy.I asked what was in it.She said just mint oil and lavender oil.Immediately after she applied it, the room started spinning and i didn't know where i was.She helped me to the waiting room, where i started vomiting.She ran out of the room claiming she was allergic to vomit, so i had to vomit on myself.I couldn't walk, stand, move for hours.I couldn't drive obviously, so had to get transportation home.It didn't wear off for about two days, during which i felt extremely ill.Various ones all contain peg.Was not taking any meds or vitamins at the time.

• Brand Name: ULTRASOUND GEL
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• MDR Report Key: 16674734
• MDR Text Key: 312706046
• Report Number: MW5116262
• Device Sequence Number: 1
• Product Code: IYO
• 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: 03/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 72 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White