SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ COMPOSITE MESH; MESH, SURGICAL, POLYMERIC
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Model Number PCO9 |
Device Problems
Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abdominal Pain (1685); Adhesion(s) (1695); Erosion (1750); Foreign Body Reaction (1868); Failure of Implant (1924); Inflammation (1932); Ischemia (1942); Pain (1994); Hernia (2240); Injury (2348); Obstruction/Occlusion (2422); Foreign Body In Patient (2687); Unspecified Tissue Injury (4559)
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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 supraumbilical ventral hernia.It was reported that after implant, the patient experienced failed mesh causing recurrence with some ragged edges on the mesh.Post-operative patient treatment included revision surgery.Relevant tests/laboratory data: (b)(6) 2015: op note refers to radiologic findings of a recurrent incarcerated ventral hernia with failed mesh and loops of small bowel and omentum through the defect.On (b)(6) 2015: path report from mesh removal showed mesh and adherent fibromembranous soft tissue with foreign body giant cell reaction.
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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.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.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 supraumbilical ventral hernia.It was reported that after implant, the patient experienced failed mesh causing recurrence with some ragged edges on the mesh, adhesions, ischemic bowel, abdominal pain, foreign body, small bowel obstruction, and severe chronic inflammation.Post-operative patient treatment included hernia revision surgeries, lysis of adhesions, small bowel resection, diagnostic laparoscopy, omentectomy and removal of foreign body.
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Manufacturer Narrative
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Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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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 supraumbilical ventral hernia.It was reported that after implant, the patient experienced failed mesh causing recurrence with some ragged edges on the mesh, adhesions, ischemic bowel, abdominal pain, foreign body, small bowel obstruction, pain, and severe chronic inflammation.Post-operative patient treatment included hernia revision surgeries, lysis of adhesions, small bowel resection, diagnostic laparoscopy, omenectomy and removal of foreign body.Relevant tests/laboratory data: 19 may 2015: op note refers to radiologic findings of a recurrent incarcerated ventral hernia with failed mesh and loops of small bowel and omentum through the defect.19 may 2015: path report from mesh removal showed mesh and adherent fibromembranous soft tissue with foreign body giant cell reaction.
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Search Alerts/Recalls
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