MAUDE Adverse Event Report: ULTRASOUND SCANNER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Flatus (1865); Pain (1994); Burning Sensation (2146); Abdominal Distention (2601)

Event Date 09/24/2018

Event Type  Injury  

Event Description

About an hour after a pelvic ultrasound/transvaginal ultrasound, i started to have labor-like pain.I started feeling bloated.I got sharp pain when eating solid food.On the second day, i started hearing gangling and buddling in my abdomen.I have previously had heat sensation from ultrasound and informed the tech prior to the procedure.I suspect that i suffered cavitation (gas formation) from the ultrasound.I am still in severe pain.Transvaginal ultrasound was performed at rush medical ctr, radiology, chicago il.I called the clinic and asked them to check their equipment, and amend my record with the after-effects.The records was not amended.My concerns was ignored.Property of (b)(6).

• Brand Name: ULTRASOUND SCANNER
• Type of Device: ULTRASOUND SCANNER
• MDR Report Key: 7922583
• MDR Text Key: 122445137
• Report Number: MW5080227
• Device Sequence Number: 1
• Product Code: IYN
• 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: 09/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 09/24/2018
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 51 YR
• Patient Weight: 57