Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.There were multiple 510k numbers that could apply as manufacturer is unknown the information for both 510k is as follows: pma / 510(k)#: k151766 ((b)(4)), k1107771 ((b)(4)).Device manufacture date: unknown.Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.We would be very interested in examining product that does not meet your expectations and our quality standards.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.Examination of the product involved may provide clarification as to the cause for the reported failure.We appreciate you taking the time to bring this observation to our attention.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
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