SOFRADIM PRODUCTION SAS MESH SOFRADIM- PARIETEX COMPOSITE MESH; MESH, SURGICAL, POLYMERIC
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Model Number PCO1510 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
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Patient Problems
Adhesion(s) (1695); Fever (1858); Unspecified Infection (1930); Pain (1994); Hernia (2240); Ascites (2596); Bowel Perforation (2668); Fluid Discharge (2686); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
Injury
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a hernia.It was reported that after the implant, the patient experienced recurrence, infection adhesions and pain.Post-operative patient treatment included revision surgery and hernia repair with mesh.
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Search Alerts/Recalls
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