SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ COMPOSITE MESH; MESH, SURGICAL, POLYMERIC
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Model Number PCO2015 |
Device Problems
Migration or Expulsion of Device (1395); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
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Patient Problems
Adhesion(s) (1695); Hyperemia (1904); Failure of Implant (1924); Unspecified Infection (1930); Nausea (1970); Necrosis (1971); Pain (1994); Seroma (2069); Vomiting (2144); Hernia (2240); Injury (2348); Obstruction/Occlusion (2422); Bowel Perforation (2668); Fibrosis (3167); No Code Available (3191); Unspecified Tissue Injury (4559)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).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 laparoscopic treatment of an incisional hernia.It was reported that after implant, the patient experienced severe pain, hernia recurrence; hernia incarceration, adhesions, mesh failure, strangulation, necrosis, perforation of bowel, obstruction, fibrovascular tissue with hyperemia, nausea, vomiting, and multiloculated seroma.Post-operative patient treatment included appendectomy, small bowel resection placement of wound vac and removal surgery.
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Manufacturer Narrative
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Additional information: b5, g4, h6.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 laparoscopic treatment of an incisional hernia.It was reported that after implant, the patient experienced severe pain, hernia recurrence; hernia incarceration, mesh failure, strangulation, necrosis, perforation of bowel, obstruction, fibrovascular tissue with hyperemia, nausea, vomiting, chronic pain, adhesions, bunching/wrinkling/curling/detachment/migration, and multioculated seroma.Post-operative patient treatment included, appendectomy, small bowel resection placement of wound vac and removal surgery.
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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 laparoscopic treatment of an incisional hernia.It was reported that after implant, the patient experienced severe pain, hernia recurrence; hernia incarceration, mesh failure, strangulation, necrosis, perforation of bowel, obstruction, fibrovascular tissue with hyperemia, nausea, vomiting, chronic pain, adhesions, bunching/wrinkling/curling/detachment/migration, and multioculated seroma.Post-operative patient treatment included, appendectomy, small bowel resection placement of wound vac and removal surgery.
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Manufacturer Narrative
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(removed patient code).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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Manufacturer Narrative
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Additional info: b5, h6 (removed codes, added patient codes, imf codes and device code).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 laparoscopic treatment of an incisional hernia.It was reported that after implant, the patient experienced infection, severe pain, hernia recurrence, hernia incarceration, mesh failure, strangulation, necrosis, perforation of bowel, obstruction, fibrovascular tissue with hyperemia, nausea, vomiting, chronic pain, adhesions, bunching/wrinkling/curling/detachment/migration, and multioculated seroma.Post-operative patient treatment included lysis of adhesions, appendectomy, small bowel resection placement of wound vac and removal surgery.
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Search Alerts/Recalls
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