SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ OPTIMIZED COMPOSITE MESH; MESH, SURGICAL, POLYMERIC
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Model Number PCO6VP |
Device Problems
Product Quality Problem (1506); Adverse Event Without Identified Device or Use Problem (2993); Torn Material (3024)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/18/2017 |
Event Type
malfunction
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Manufacturer Narrative
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To date, the incident sample has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained, a follow-up report will be submitted.If information is provided in the future, a supplemental report will be issued.
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Event Description
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According to the reporter, post-operatively the mesh was torn.The mesh was implanted during an umbilical hernia repair, while doing an open repair operative approach and after insertion into the patient, the mesh was wet after soaking water.The mesh is soaked in saline after opening before being implanted.There were 4 fixation points used for the suture in the wound closure.The doctor suspected that one of the flaps on the mesh was damaged by accident after the patient was discharged.The patient has no injury.
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Search Alerts/Recalls
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