The event unit was not returned to applied medical for evaluation and the lot number was not provided.As the event unit was not returned, testing was unable to be performed and the complainant¿s experience could not be replicated or confirmed.In the absence of the event unit, it is difficult to determine the exact root cause of the event.Applied medical has reviewed the details surrounding the event and related product.At this time, applied medical is unable to confirm that a product malfunction occurred.Applied medical will monitor its vigilance systems for any developing trends.This report represents a combined initial and follow-up report.
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