It was reported that the physician injected half of solesta gel into the consumer's prostate on (b)(6) 2014; subsequently, the consumer suffered renal failure, pain and become septic.The consumer alleged that the physician did not follow proper procedure.No additional information was provided.
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The device was not returned to b+l for evaluation; therefore, product evaluation could not be conducted.The lot number of the device was not provided; therefore, a batch record review (brr)could not be performed.Based on the information available, the exact cause of the reported event could not be conclusively determined.
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