Device 1 of 2.Contact office address: (b)(4).Based on the available information, this event is deemed to be a serious injury.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.(b)(4).
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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 correction (g1) - contact office address: (b)(4).Batch record review: lot 7h00390 was manufactured on 09/aug/2017, in the 11e manufacturing line with a total of (b)(4) mkus.Complaint investigator id (b)(4) performed a batch record review on 18/nov/2021, to verify if all the applicable procedures were followed and no issues were found, all the components for assembly were correct per bom and all the tooling information documented was also correct, sap material id 1003643 and manufacturing order (b)(4).No discrepancies related to the issue reported were found.Returned sample evaluation: no photos were received and no unused return samples were expected.Conclusion summary of the related event: 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 is not enough information about how the product was used that leads us to a conclusion, therefore, there is not product malfunction confirmed.In addition, per customer description, the cause of urinary tract infection reported for lot 7h00390 is related to the clip crack/break and this defect was addressed by another the record in the database.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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