Device 8 of 10.Based on the available information, this event is deemed to be a serious injury.No product malfunction is considered for this emdr as bowel obstruction may have contributed to fungal infection issue.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number: (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 h6: imdrf investigation findings : c24 is captured for the issue malfunction observed without conclusive finding an investigation was completed for this complaint by the assigned manufacturing site investigation team.The complaint summary of this investigation required rework.A corrective actions/preventive actions (capa) was raised, and an updated/corrected investigation summary has been completed in accordance with assigned capa.A supplemental mdr is being submitted to document the completion of investigation rework and final investigation; the complaint record will proceed to closure.Lot 2e00207 was manufactured on 05/04/2022 and this was the only complaint found in database.Hence, no full cause investigation was carried out.No return samples were provided.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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