MAUDE Adverse Event Report: ULTRASOUND EQUIPMENT; ULTRASONIC PULSED DOPPLER IMAGING SYSTEM

Device Problem Use of Device Problem (1670)

Patient Problems Pain (1994); Constipation (3274)

Event Date 11/02/2018

Event Type  Injury  

Event Description

Nephrologist ordered ultrasound of kidneys and pelvic region.What sound have taken a few mins turned into marathon with the tech doing the procedure over and over again.She was very rough and dug into my body with the device.The day after the procedure i began to have excruciating pain in my pelvic area, and i have not been able to have a bowel movement.

• Brand Name: ULTRASOUND EQUIPMENT
• Type of Device: ULTRASONIC PULSED DOPPLER IMAGING SYSTEM
• MDR Report Key: 8106479
• MDR Text Key: 128656351
• Report Number: MW5081639
• 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: 11/25/2018

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/26/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 70 YR
• Patient Weight: 67