Additional information (h10) - this emdr is being submitted to include the below: h6 - investigation results under imdrf cause investigation code, imdrf investigation findings, imdrf cause conclusions h10: investigation summary: correction (g1) - contact office address: (b)(4) 7815 national service road suite 600 greensboro, nc 27409 336-542-4679.No sample, video or photo was received for evaluation; for that reason, the malfunction reported by the customer could not be confirmed.Batch record review results: lot 1b00108 was manufactured on 02/10/2021 in the 11d manufacturing line, with a total of (b)(4) mkus.On 11/25/2021, complaint investigator id 6055 performed a batch record review, to verify if all the applicable procedures were followed and no issues were found; all the components for assembly were correct per bom, under sap material (b)(4) and manufacturing order (b)(4).No issues related to the defect were found in the documentation.On 11/25/2021 a complaint search for lot 1b00108 and malfunction was carried out and as a result, no additional complaints were found; therefore, no potential trend was observed.As per complaint manufacturing investigation, it is not required to open a nonconformance report (ncr) for type 2 complaints which were not confirmed and no potential trend is identified.No additional action is required, and this complaint will be closed.This issue will be monitored through the post market product monitoring review process.The investigation associated with related event was approved and complete.No additional action is required, and this complaint will be closed.This issue will be monitored through the post market product monitoring review process.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number.Reporting site: 1049092.Manufacturing site: 9618003.
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