SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ COMPOSITE MESH; MESH, SURGICAL, POLYMERIC
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Model Number PCO3020 |
Device Problems
Material Erosion (1214); Migration or Expulsion of Device (1395); Material Perforation (2205); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
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Patient Problems
Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Erosion (1750); Purulent Discharge (1812); Fistula (1862); Unspecified Infection (1930); Inflammation (1932); Nausea (1970); Internal Organ Perforation (1987); Pain (1994); Vomiting (2144); Hernia (2240); Injury (2348); Obstruction/Occlusion (2422); Bowel Perforation (2668); 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 resulting in an unspecified adverse outcome.Product was used for therapeutic treatment.The patient has had pain, adherence, and 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.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.Product was used for therapeutic treatment of an incisional hernia.The patient has had pain, infection, abscess, fistula, mesh erosion into viscera, and adhesions.Post-operative patient treatment included revision surgery, small bowel resection, and mesh removal.
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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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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.Product was used for therapeutic treatment of an incisional hernia.It was reported that after underlay implant, the patient experienced hospitalization for pain, infection, abscess, fistula, mesh erosion into viscera, adhesions, colon perforation, fibrinous serositis and suppuration in colon resection, nausea, omitting, and gastroparesis.Post-operative patient treatment included revision surgery, small bowel resection, and mesh removal.
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Event Description
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The patient's attorney alleged a deficiency against the device.Product was used for therapeutic treatment of an incisional hernia.It was reported that after underlay implant, the patient experienced hernia recurrence, mesh migration, serosal bladder injury, pain, infection, abscess, fistula, mesh erosion into viscera, adhesions, colon perforation, fibrinous serositis, suppuration, nausea, omitting, and gastroparesis.Post-operative patient treatment included revision surgery, small bowel resection, hospitalization, and mesh removal.
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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: b5, b7, d4 (expiration date), h4, h6 (patient codes), additional codes.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.Product was used for therapeutic treatment of an incisional hernia.It was reported that after underlay implant, the patient experienced inflammation, obstruction, abscess, abdominal pain, hernia recurrence, mesh migration, serosal bladder injury, pain, infection, abscess, fistula, mesh erosion into viscera, adhesions, colon perforation, fibrinous serositis, suppuration, nausea, omitting, and gastroparesis.Post-operative patient treatment included partial mesh revision, ct-scan, antibiotics, wound vac, revision surgery, small bowel resection, hospitalization, mesh removal, and hernia repair with new mesh.Relevant tests/laboratory data: (b)(6) 2012: per op note, ct scan of abdomen demonstrated a subcutaneous abscess cavity with frank colonic perforation adherent to the cavity & mesh incorporated within cavity.(b)(6) 2012: surgical pathology report found fibrinous serositis and suppuration in colon resection & abscess excision of fibrofatty tissue with abscess formation.
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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.Product was used for therapeutic treatment of an incisional hernia.It was reported that after underlay implant, the patient experienced inflammation, obstruction, abscess, abdominal pain, hernia recurrence, mesh migration, serosal bladder injury, pain, infection, abscess, fistula, mesh erosion into viscera, adhesions, colon perforation, fibrinous serositis, & suppuration.Post-operative patient treatment included partial mesh revision, ct-scan, antibiotics, wound vac, revision surgery, small bowel resection, hospitalization, mesh removal, hernia repair with new mesh, & abscess excision.
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