SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ OPTIMIZED COMPOSITE MESH; MESH, SURGICAL, POLYMERIC
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Model Number PCO2015OSX |
Device Problems
Loss of or Failure to Bond (1068); Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Dehydration (1807); Purulent Discharge (1812); Failure of Implant (1924); Unspecified Infection (1930); Necrosis (1971); Pneumonia (2011); Renal Failure (2041); Staphylococcus Aureus (2058); Sepsis (2067); Shock (2072); Hernia (2240); Injury (2348); Impaired Healing (2378); Ventilator Dependent (2395); Obstruction/Occlusion (2422); No Code Available (3191)
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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 implant, the patient experienced recurrent hernia due to failure of the mesh, bowel obstruction, adhesions, infected mesh, and component separation of the mesh.Treatment provided for these conditions include removal surgery.
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Manufacturer Narrative
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This information was received as a part of an extensive mesh litigation submission to medtronic. the fda was notified of this large complaint receipt. due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target.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 an open central hernia.It was reported that after implant, the patient experienced recurrent hernia due to failure of the mesh, purulent discharge, (b)(6), sepsis, shock, delirium, pneumonia, ventilator support, dehydration, acute renal failure, mesh migration, necrosis, non-healing wound, bowel obstruction, adhesions and infected mesh.Post-operative patient treatment included removal of infected mesh, lysis of adhesions, debridement of skin and subcutaneous tissue, partial omentectomy, complex reconstruction of abdominal wall, bilateral anterior component separation with retrorectus placement of biologic mesh, primary closure of fascia in the midline, placement of wound vac dressing, removal of necrotic fat to improve wound healing, washout of wound, esophagogastroduodenoscopy and tiger tube placement in small bowel.
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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 ventral incisional hernia.It was reported that after underlay implant, the patient experienced recurrent hernia due to failure of the mesh, purulent discharge, (b)(6), sepsis, shock, delirium, pneumonia, ventilator support, dehydration, severe protein-calorie malnutrition, acute renal failure, mesh migration, necrosis, non-healing wound, bowel obstruction, adhesions and infected mesh.Post-operative patient treatment included removal of infected mesh, lysis of adhesions, debridement of skin and subcutaneous tissue, partial omentectomy, complex reconstruction of abdominal wall, bilateral anterior component separation with retrorectus placement of biologic mesh, primary closure of fascia in the midline, placement of wound vac dressing, removal of necrotic fat to improve wound healing, washout of wound, esophagogastroduodenoscopy and tiger tube placement in small bowel.
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Manufacturer Narrative
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This information was received as a part of an extensive mesh litigation submission to medtronic.The fda was notified of this large complaint receipt.Due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target.If information is provided in the future, a supplemental report will be issued.
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