Additional information - 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 batch record review: lot 1e00743 was manufactured on 26/may/2021, in the aps 6 automated manufacturing line with a total of (b)(4) market units (mkus).Complaint investigator performed a batch record review on 12/aug/2022, to verify if all the applicable procedures were followed and no issues were found, all the components for assembly were correct per bill of materials (bom) and all the tooling information documented was also correct, sap material id 1708131 and manufacturing order 1571440.No discrepancies related to the issue reported were found.The disc used in the manufacturing process of batch 1e00743 was the part number 1707112 (disc esteem s/hesive moldable cmt 20/30), bulk lot 1e02077, manufactured in the cmt manufacturing line under procedure instruction (pi).All the components used were correct per bom and all the tooling information documented was also correct.No discrepancies related to the issue reported were found.Historical complaints review: on (b)(6) 2022, complaint investigator ran a query in database in order to verify the complaints reported for the batches listed in the table and as result, a total of two (2) complaints were found reported.However, only one of these complaints was related to the malfunction code involved in this investigation.Returned sample evaluation: no photographs associated with this case and no unused return sample was expected.Conclusion: based on the preliminary investigation performed, no issues related to the customer experience were found in the batch record review.No significant changes have been made in the process or in the product components that could cause the adverse effects reported by the customer.The product was used in their shelf life.No photos or samples were received and per customer description there was not enough information about how the product was used that leads us to a conclusion, therefore, there was not product malfunction confirmed.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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