SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ COMPOSITE MESH; MESH, SURGICAL, POLYMERIC
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Model Number PCO3728 |
Device Problems
Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
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Patient Problems
Corneal Pannus (1447); Abdominal Pain (1685); Adhesion(s) (1695); Edema (1820); Hematoma (1884); Hemorrhage/Bleeding (1888); Ischemia (1942); Nausea (1970); Vomiting (2144); Hernia (2240); Injury (2348); Impaired Healing (2378); Obstruction/Occlusion (2422); Abdominal Distention (2601); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)
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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 an incarcerated ventral hernia.It was reported that after implant, the patient experienced partial removal of covidien mesh, recurrent ventral hernia repair with new mesh, small bowel obstruction, previous mesh pulled away from inferior fascia, extensive adhesions, abdominal pain, nausea, vomiting, abdominal distention, recurrent incarcerated incisional hernia repaired with new mesh, and wound vac placed.Post-operative patient treatment included additional surgery.Relevant tests/laboratory data: (b)(6) 2010 abdominal ct showed small bowel obstruction with edema in the mesentery concerning for bowel wall ischemia.
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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 laparoscopic therapeutic treatment of a recurrent incarcerated ventral hernia.It was reported that after implant, the patient experienced recurrence, edema, bowel wall ischemia, small bowel obstruction, previous mesh pulled away from inferior fascia, extensive adhesions, abdominal pain, nausea, vomiting, open wound, abdominal distention, and abdominal pannus.Post-operative patient treatment included partial removal of covidien mesh,recurrent ventral hernia repair with new mesh, recurrent incarcerated incisional hernia repaired with new mesh, panniculectomy, wound vac placed and additional surgery.
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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 incarcerated ventral hernia.It was reported that after implant, the patient experienced recurrence, small bowel obstruction, previous mesh pulled away from inferior fascia, extensive adhesions, abdominal pain, nausea, vomiting, open wound and abdominal distention.Post-operative patient treatment included partial removal of covidien mesh, recurrent ventral hernia repair with new mesh, recurrent incarcerated incisional hernia repaired with new mesh, wound vac placed and additional surgery.
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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 laparoscopic therapeutic treatment of a recurrent incarcerated ventral hernia.It was reported that after implant, the patient experienced hematoma, bleeding, unincorporated mesh, incarcerated hernia, serosal tear, recurrence, edema, bowel wall ischemia, small bowel obstruction, previous mesh pulled away from inferior fascia, extensive adhesions, abdominal pain, nausea, vomiting, open wound, abdominal distention, and abdominal pannus.Post-operative patient treatment included partial removal of covidien mesh, recurrent ventral hernia repair with new mesh, recurrent incarcerated incisional hernia repaired with new mesh, panniculectomy, wound vac placed, ct-scan, use of drains, organ loss, panniculectomy, and additional surgery.Relevant tests/laboratory data: 14 apr 2010 abdominal ct showed small bowel obstruction with edema in the mesentery concerning for bowel wall ischemia.
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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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Additional information: additional code f1905.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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