Udi information is unknown.Operator of device is unknown.No information has been provided to date.Manufacturing site address is unknown.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.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.A product sample was received for evaluation.Visual and functional testing were performed.The sample was found to have embedded resin, and the circuit did not pass the leak test.Unable to determine the root cause of the reported issue.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
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