Actual device was not returned to richard wolf (b)(4) for evaluation as of 03/25/2016.No similar complaints on this specific product or any similar products have been reported in the last five years.Labeling was reviewed and found to be adequate.Facility has acknowledged a major change in staffing, which has resulted in failure to follow facilities reprocessing instructions as well as manufacturers ifu.Facility has taken steps in order to greatly reduce likelihood of similar events from occurring in the future.Facility has been contacted in order to gather additional information needed for this report no response as of 03/25/2016.This incident does not represent a reportable event that requires remedial action to prevent an unreasonable risk of substantial harm to the public's health.Rw (b)(4) considers this matter closed.However, in the event additional information is received, rw (b)(4) will provide fda with follow-up information.(b)(4).
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