DATE: April 18, 2012
AUDIENCE: Risk Manager, OB/GYN, Radiology, Infectious Disease
ISSUE: FDA notified health care professionals and facilities to STOP using Other‐Sonic Generic Ultrasound Transmission Gel manufactured June though December 2011, because of bacterial contamination with the bacteria Pseudomonas aeruginosa and Klebsiella oxytoca. The contamination was found in lot numbers 060111, 090111, and 120111. These lots are sold in 250 milliliter (mL) bottles and 5 liter (l) dispensing containers.
Pseudomonas aeruginosa is found most often in water and soil. Patients exposed to the bacteria on the surface of their skin could develop inflammatory dermatitis, even on intact skin. Klebsiella bacteria is often found in the digestive tract where they do not often cause infection; however, when the lungs or other tissues are exposed to Klebsiella bacteria, either minor problems or more serious infections, such as pneumonia, wound infection, or bloodstream infections, could occur.
BACKGROUND: Other‐Sonic Generic Ultrasound Transmission Gel, manufactured by Pharmaceutical Innovations Inc. is a non‐sterile gel used in ultrasound procedures to improve the transmission of the ultrasound signal from the transducer to the body.
RECOMMENDATION: 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.
Health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
To help us learn as much as possible about the adverse events associated with Other‐Sonic Generic Ultrasound Transmission Gel, please include the following information in your reports, if available:
Read the MedWatch safety alert, including a link to the FDA Safety Communication, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm300873.htm
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