Manufacturing site address is unknown.Udi information is unknown.Operator of device is unknown.No information has been provided to date.Premarket (510k) number is unknown.A product sample was received for evaluation.Visual and functional testing were performed.The reported event was confirmed.The root cause may be due to manufacturing.A secondary evaluation was performed confirming the supplied item as faulty.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
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