Udi information is unknown.Initial reporter also sent report to fda is unknown.No information has been provided to date.Manufacturing site address is unknown.Premarket (510k) number is unknown.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual and functional testing were performed.Reported failure was unable to be reproduced.Root cause cannot be determined since the complaint was not confirmed due to the fact the sample was tested and successfully passed.This remediation mdr was generated under protocol (b)(4), as a result of warning letter (b)(4).
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