(b)(4).Therapy dates - the exact occurrence date is unknown; however, the event was reported to have occurred in the six months prior to the report.The device was manufactured 08/23/2013 - 08/27/2013.The device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Simulated use testing, pull testing, and pressure testing were performed with no issues noted.The device was found to operate per specification.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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