Need a Texas Other-Sonic Ultrasound Gel Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one was diagnosed with a bacterial infection caused by surgical gel, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit in Texas.
Other-Sonic Ultrasound Gel Recall
March 2012 — The FDA issued a Class 1 recall for Other-Sonic Ultrasound Gel due to possible bacterial contamination.
In 2011, the gel was linked to 16 reports of infection at William Beaumont Hospital in Royal Oak, Michigan. FDA testing discovered contamination with pseudomonas aeruginosa, and klebsiella oxytoca bacteria.
The Centers for Disease Control (CDC) investigation found that all of the patients underwent a transesophageal ultrasound probe (echocardiography), in which Other-Sonic Generic Ultrasound Transmission Gel was used to guide an ultrasound down a patient’s throat to create a picture of the heart and blood vessels. Testing of an unopened bottle of the gel found contamination with P. aeruginosa.
In April, the FDA ordered U.S. Marshals to seize certain lots of the product from the manufacturer. Unfortunately, the products were not manufactured in conformance with FDA regulations and they were sold without pre-market approval or clearance.
What is the problem?
Not every patient who is exposed to the bacteria will develop an infection. However, patients exposed to P. aeruginosa on the surface of their skin could develop inflammatory dermatitis (rash), even on intact skin. If the bacteria carried into the body (on an ultrasound, for example), it could cause an abscess, sepsis, tracheobronchitis, or pneumonia.
- Bloodstream infection
Ultrasound Gel Infection Lawsuits
According to Melinda K. Plaisier, the FDA’s associate commissioner for regulatory affairs:
“Despite multiple warnings by the FDA over the past three years, and promises to correct the numerous ongoing violations, the defendants continued to violate the law. This presents serious health risks to patients who used and continue to use the company’s products.”
Need a Other-Sonic Ultrasound Gel Lawyer in Texas?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $260 million in verdicts and/or settlements. Please use the form below to contact our Texas Other-Sonic Ultrasound Gel lawyers for a free lawsuit review.