SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ COMPOSITE MESH; MESH, SURGICAL, POLYMERIC
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Model Number TET1515 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Purulent Discharge (1812); Emotional Changes (1831); Erythema (1840); Fistula (1862); Foreign Body Reaction (1868); Granuloma (1876); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Pain (1994); Staphylococcus Aureus (2058); Scar Tissue (2060); Scarring (2061); Hernia (2240); Discomfort (2330); Injury (2348); Deformity/ Disfigurement (2360); Impaired Healing (2378); Obstruction/Occlusion (2422); Fibrosis (3167); No Code Available (3191); Unspecified Tissue Injury (4559)
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Event Type
Death
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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 hernia.It was reported that after implant, the patient experienced chronic pain, fistula, extensive adhesions, infection, revision, debridement.
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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.The product was used for therapeutic treatment of a ventral incisional hernia.It was reported that after implant, the patient experienced chronic pain, fistula, extensive adhesions, infection, recurrence, open wound, slow healing noted to worsen with granulation tissue no longer present, erythema, foreign material, dense fibrous scar, chronic inflammation, foreign body giant cell reaction and staphylococcus.Post-operative patient treatment included revision surgery and excision of mesh.
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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 incisional hernia.It was reported that after implant, the patient experienced chronic pain, fistula, extensive adhesions, infection, recurrence, open wound, slow healing noted to worsen with granulation tissue no longer present, erythema, foreign material, dense fibrous scar, chronic inflammation, foreign body giant cell reaction and staphylococcus.Post-operative patient treatment included revision 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 treatment of a ventral incisional hernia.It was reported that after implant, the patient experienced chronic pain, fistula, extensive adhesions, infection, recurrence, open wound, slow healing noted to worsen with granulation tissue no longer present, erythema, foreign material, dense fibrous scar, chronic inflammation, foreign body giant cell reaction, staphylococcus, mental pain, suffering, physical deformity, impaired quality of life, disability, permanent impairment, loss of enjoyment of life, small bowel obstruction, stich granuloma, abdominal wall abscess, purulence, necrotic tissues, & death.Post-operative patient treatment included revision surgery, excision of mesh, hernia repair with mesh, hernia repair surgery, exploratory laparotomy for small bowel obstruction, extensive enterolysis, lysis of adhesions, debridement of the abdominal wall with removal of stich granuloma, multiple incision/drainage/debridement procedures of abdominal wall abscess, & medical treatment.Information received indicates the patient is deceased.No information was provided regarding the circumstances of expiration.
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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 info: b5 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.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 incisional hernia.It was reported that after implant, the patient experienced improper wound healing, chronic pain, fistula, extensive adhesions, infection, recurrence, open wound, slow healing noted to worsen with granulation tissue no longer present, erythema, foreign material, dense fibrous scar, chronic inflammation, foreign body giant cell reaction, staphylococcus, mental pain, suffering, physical deformity, impaired quality of life, disability, permanent impairment, loss of enjoyment of life, small bowel obstruction, stich granuloma, abdominal wall abscess, purulence, necrotic tissues, & death.Post-operative patient treatment included revision surgery, mesh revision, excision of mesh, hernia repair with meshes, hernia repair surgery, exploratory laparotomy for small bowel obstruction, extensive enterolysis, lysis of adhesions, debridement of the abdominal wall with removal of stich granuloma, multiple incision/drainage/debridement procedures of abdominal wall abscess, & medical treatment.Information received indicates the patient is deceased.No information was provided regarding the circumstances of expiration.
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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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