SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ COMPOSITE MESH; MESH, SURGICAL, POLYMERIC
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Model Number PCO12 |
Device Problems
Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001); Material Split, Cut or Torn (4008)
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Patient Problems
Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Erosion (1750); Foreign Body Reaction (1868); Unspecified Infection (1930); Inflammation (1932); Internal Organ Perforation (1987); Pain (1994); Seroma (2069); Discharge (2225); Hernia (2240); Ulcer (2274); Injury (2348); Fluid Discharge (2686); Fibrosis (3167); 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.The product was used for therapeutic treatment of a ventral hernia.It was reported that after implant, the patient experienced mesh wadded into ball, recurrence, pain, and adhesions.Treatment provided for these conditions included surgical revision in (b)(6) 2010.Relevant tests/lab data: (b)(6) 2010 pathology report showed benign hernia sac without significant inflammation and surgical mesh.
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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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.The product was used for therapeutic treatment of a ventral hernia.It was reported that after implant, the patient experienced mesh wadded into ball, recurrence, pain, abscess, infection, mesh erosion into viscera, and adhesions.Post-operative patient treatment included surgical revisions, excision of mesh, able to free up numerous adhesions of the small bowel to the hernia sac, and abscess dissection free using electrocautery and removed.Relevant tests/lab data: (b)(6) 2010 pathology report showed benign hernia sac without significant inflammation and surgical mesh.
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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.H6:patient code-c64343(microsuppuration, pneumoperitoneum).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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.The product was used for therapeutic treatment of a ventral hernia.It was reported that after implant, the patient experienced mesh wadded into ball, recurrence, pain, abscess, infection, mesh erosion into viscera, inflammation, fibrosis, foreign body granulomatous inflammation and microsuppuration, pneumoperitoneum, ulcer, perforation of gastrojejunostomy, mesh found freed up, drainage, abdominal pain, and adhesions.Post-operative patient treatment included surgical revisions, able to free up numerous adhesions of the small bowel to the hernia sac, debridement of abdominal wall with removal of infected mesh and subcutaneous tissue, admitted to the hospital, panniculectomy, drainage of seroma, resect ulcer, revision gastrojejunostomy, partial gastrectomy, enterolysis, gastrostomy tube placement, cecopexy, appendectomy, close mesenteric space and petersen¿s space, and abscess dissection free using electrocautery and removed.
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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 hernia.It was reported that after implant, the patient experienced seroma, mesh split in two, mesh wadded into ball, recurrence, pain, abscess, infection, mesh erosion into viscera, inflammation, fibrosis, foreign body granulomatous inflammation and microsuppuration, pneumoperitoneum, ulcer, perforation of gastrojejunostomy, mesh found freed up, drainage, abdominal pain, and adhesions.Post-operative patient treatment included surgical revisions, able to free up numerous adhesions of the small bowel to the hernia sac, debridement of abdominal wall with removal of infected mesh and subcutaneous tissue, enterotomy, anastomosis, admitted to the hospital, panniculectomy, drainage of seroma, resect ulcer, revision gastrojejunostomy, partial gastrectomy, enterolysis, gastrostomy tube placement, cecopexy, appendectomy, close mesenteric space and petersen¿s space, hernia repair with mesh, and abscess dissection free using electrocautery and removed.
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Manufacturer Narrative
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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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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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Manufacturer Narrative
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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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.The product was used for therapeutic treatment of a ventral hernia.It was reported that after implant, the patient experienced seroma, mesh split in two, mesh wadded into ball, recurrence, pain, abscess, infection, mesh erosion into viscera, inflammation, fibrosis, foreign body granulomatous inflammation and microsuppuration, pneumoperitoneum, ulcer, perforation of gastrojejunostomy, mesh found freed up, drainage, abdominal pain, work disability, and adhesions.Post-operative patient treatment included surgical revisions, able to free up numerous adhesions of the small bowel to the hernia sac, debridement of abdominal wall with removal of infected mesh and subcutaneous tissue, enterotomy, anastomosis, admitted to the hospital, panniculectomy, drainage of seroma, resect ulcer, revision gastrojejunostomy, partial gastrectomy, enterolysis, gastrostomy tube placement, cecopexy, appendectomy, close mesenteric space and petersen¿s space, hernia repair with mesh, ct scan, medication, and abscess dissection free using electrocautery and removed.Relevant tests/lab data: 15 jul 2010: pathology report showed benign hernia sac without significant inflammation and surgical mesh 07 sep 2010: pathology report showed fibrosis, foreign body granulomatous inflammation and microsuppuration with associated inflamed granulation tissue.15 oct 2011: op note- ct found massive pneumoperitoneum as well as findings suggestive of internal hernia.
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