Other-Sonic Generic Ultrasound Transmission Gel Poses Risk of Bacterial Contamination

FDA alerts Risk Managers, OB/GYN, Radiology, Infectious Disease healthcare professionals to STOP using Other-Sonic Generic Ultrasound Transmission Gel, manufactured from June to December 2011, because it poses risk of bacterial contamination.

Background of Other-Sonic Generic Ultrasound Transmission Gel

Other-Sonic Generic Ultrasound Transmission Gel, manufactured by Pharmaceutical Innovations Inc., is a gel used by medical professionals in ultrasounds a procedure during which high-frequency sound waves are used to look at organs inside the body.

Other-Sonic Generic Ultrasound Transmission Gel

FDA Alert on Other-Sonic Generic Ultrasound Transmission Gel

After the FDA received a report from a hospital that 16 patients had developed colonization or infection with the bacteria Pseudomonas aeruginosa following their examination with transesophageal ultrasound probes using Other-Sonic Generic Ultrasound Transmission Gel, the agency tested unopened bottles of the gel at the hospital and the manufacturing company’s facility. The results of the test revealed that the gel contained significant amounts of Pseudomonas aeruginosa and Klebsiella oxytoca.

Patients exposed to the bacteria could develop inflammatory dermatitis. Moreover, the bacteria could cause abscess or sepsis, tracheobronchitis or pneumonia, wound or bloodstream infections.

The contamination was found in lot numbers 060111, 090111, and 120111, sold in 250 mL bottles and 5 liter dispensing containers.

Other-Sonic Generic Ultrasound Transmission Gel

On April 18, 2012, the FDA notified about the seizure of Other-Sonic Generic Ultrasound Transmission Gel located at Pharmaceutical Innovations, Inc. Newark, N.J.

FDA Recommendation on Other-Sonic Generic Ultrasound Transmission Gel

Healthcare professionals “Do NOT use Other‐Sonic Generic Ultrasound Transmission Gel from lot numbers 060111 through 120111. Identify patients who have been exposed to these lots of Other‐Sonic Generic Ultrasound Transmission Gel. Review the procedures they underwent and the outcomes of those procedures. Then, determine if further evaluation is needed. See the FDA Safety Communication for additional information.”

Contacting the FDA to report cases with Other-Sonic Generic Ultrasound Transmission Gel

In case of detection of adverse events or side effects related to the use of Other-Sonic Generic Ultrasound Transmission Gel, healthcare professionals and patients should report it to the FDA’s MedWatch Safety Information and Adverse Event Reporting program through any of the following ways:

The report can be completed and submitted Online at: www.fda.gov/MedWatch/report.htm

The form can be downloaded or requested by calling 1-800-332-1088, then completed and returned on the address indicated on the form

The completed form can be faxed to:  1-800-FDA-0178

The following information will be helpful, if available:

• Lot number
• Bottle size
• Date of adverse event
• Type of ultrasound procedure
• Details of the adverse event and medical intervention (if required)

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