SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ COMPOSITE MESH; MESH, SURGICAL, POLYMERIC
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Model Number PCO2520OS |
Device Problems
Migration or Expulsion of Device (1395); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abscess (1690); Adhesion(s) (1695); Emotional Changes (1831); Fistula (1862); Unspecified Infection (1930); Pain (1994); Hernia (2240); Distress (2329); Injury (2348); Impaired Healing (2378); Obstruction/Occlusion (2422); Post Operative Wound Infection (2446); No Code Available (3191); 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 resulting in an unspecified adverse outcome.Product was used for therapeutic treatment.Preoperative and postoperative diagnosis was incisional hernia.The procedure performed was open repair of incisional hernia with mesh.The patient underwent a subsequent procedure for open repair of incisional hernia.The preoperative and postoperative diagnosis was incisional hernia.The patient experienced infection, abscess, removal, non-healing wound, meshoma, and small bowel fistulas.
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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 incisional hernia.It was reported that after implant, the patient experienced recurrence, infection, abscess, non-healing wound, meshoma, adhesions, small bowel obstruction, pain, and small bowel fistulas.Post-operative patient treatment included hernia repair with mesh, removal, and revision surgery.
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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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Search Alerts/Recalls
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