No product sample was received; therefore, visual and functional testing could not be performed.If the product is returned, will reopen this complaint for further investigation.A review of the manufacturing process for was conducted by quality engineer in order to verify that there are no situations or practices that could create the event.No discrepancies were found no root cause could be determine since the complaint could not be confirmed since no samples or pictures were received for evaluation.Operator of device: patient/consumer.No information has been received to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter (b)(4).
|