SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ COMPOSITE MESH; MESH, SURGICAL, POLYMERIC
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Model Number PCO2520OS |
Device Problems
Product Quality Problem (1506); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
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Patient Problems
Abdominal Pain (1685); Adhesion(s) (1695); Erosion (1750); Unspecified Infection (1930); Sepsis (2067); Discharge (2225); Hernia (2240); Injury (2348); Impaired Healing (2378); Bowel Perforation (2668); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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A good faith effort will be made to obtain the applicable information relevant to the report.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.The patient underwent a repair of recurrent abdominal wall incisional hernia with mesh.He had revision surgery 2 years and 1 month post-surgery.The patient underwent another revision surgery 4 years and 4 months.The patient underwent exploratory with lysis of adhesions.The patient experienced adhesions.
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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 abdominal incisional hernia.It was reported that after the implant, the patient experienced mesh erosion into viscera, recurrence, adhesions, infection, mesh with foul odor with greenish discoloration, hole in colon leaking succus onto mesh, several areas of draining in the midline, abdominal pain, sepsis, and open wound.Post-operative patient treatment included revision surgery, exploratory laparotomy, removal of infected mesh, partial colectomy, placement of wound vac, repair of hernia, complex closure of abdominal wall, bilateral component separation, hernia repair aborted due to adhesions, and lysis of adhesions.
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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 abdominal incisional hernia.It was reported that after the implant, the patient experienced mesh erosion into viscera, recurrence, adhesions, infection, several areas of draining in the midline, and open wound.Post-operative patient treatment included revision surgery, exploratory laparotomy, removal of infected mesh, partial colectomy, placement of wound vac, and lysis of adhesions.
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Search Alerts/Recalls
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