Other-Sonic Ultrasound Gel is a non-sterile product that was recalled in 2012 after FDA testing discovered significant bacterial contamination. At least 16 people who were treated with this product developed infections.
What You Can Do & How an Other-Sonic Ultrasound Gel Lawsuit Can Help
The Schmidt Firm, PLLC is currently accepting Other-Sonic Ultrasound Gel induced injury cases in all 50 states. If you or somebody you know was diagnosed with a bacterial infection, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.
Overview
Other-Sonic Ultrasound Gel, manufactured by Pharmaceutical Innovations, Inc., is a non-sterile gel that is used to help improve the transmission of ultrasound signals from the transducer to the body.
What is the problem?
In March 2012, the U.S. Food and Drug Administration (FDA) issued a Class 1 recall for Other-Sonic Ultrasound Gel because it may be contaminated with bacteria.
At least 16 patients who were treated at one hospital in Michigan developed infections. When the Centers for Disease Control (CDC) investigated, they found that all of the patients were treated with Other-Sonic Ultrasound Gel during a transesophagel echocardiography.
Testing of the gel discovered significant levels ofPseudomonas aeruginosa, and klebsiella oxytoca bacteria.
Safety Risks
Infections do not occur in every patient who is exposed, but there is always a risk that bacteria will colonize tissues and cause an infection. Exposure to P. aeruginosa on the surface of the skin (even intact skin) could cause inflammatory dermatitis. If the bacteria is carried inside a patient’s body on an ultrasound, it could cause life-threatening sepsis, abscesses, or lung infections like tracheobronchitis and pneumonia.
Side Effects
- Infection
- Abscess
- Sepsis
- Pneumonia
- Tracheobronchitis
- Bloodstream infection
- Death
FDA Files Lawsuit
In October 2014, federal officials with the FDA and the Department of Justice (DOJ) filed a lawsuit against Pharmaceutical Innovations, Inc. The injunction accuses the drug-maker of violating federal by selling unapproved products that do not conform to good manufacturing practices. Click here to read more.
The FDA’s associate commissioner for regulatory affairs, Melinda K. Plaisier, stated:
“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.”
Do I have an Other-Sonic Ultrasound Gel Lawsuit?
The Schmidt Firm, PLLC is currently accepting Other-Sonic Ultrasound Gel induced injury cases in all 50 states. If you or somebody you know was diagnosed with a bacterial infection, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.
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