A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.No product sample was received for evaluation; however, a review of the manufacturing process was performed.No discrepancies were detected during visual inspection.No discrepancies were found during the inspection test.No root cause could determine since the complaint could not be confirmed since no samples or pictures were received for evaluation.No information has been received to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# 617147.
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