SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ COMPOSITE MESH; MESH, SURGICAL, POLYMERIC
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Model Number PCO2520OS |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abdominal Pain (1685); Adhesion(s) (1695); Diarrhea (1811); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Muscle Weakness (1967); Nausea (1970); Pain (1994); Scar Tissue (2060); Seroma (2069); Chills (2191); Hernia (2240); Discomfort (2330); Depression (2361); Obstruction/Occlusion (2422); Sleep Dysfunction (2517); Skin Inflammation/ Irritation (4545); Unspecified Tissue Injury (4559)
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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 laparoscopic therapeutic treatment of a ventral hernia.It was reported that after implant, the patient experienced seroma, adhesions, nausea, diarrhea, chills, inflammation, tenderness, skin irritation, loss of appetite, loss of sleep, depression, chronic pain, abdominal pain, weak abdominal wall, and suffering.Post-operative patient treatment included revision surgery, lysis of adhesions, and diagnostic laparoscopy.
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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 laparoscopic therapeutic treatment of a ventral hernia.It was reported that after implant, the patient experienced seroma, adhesions, nausea, diarrhea, chills, inflammation, tenderness, skin irritation, loss of appetite, loss of sleep, depression, chronic pain, abdominal pain, weak abdominal wall, and suffering.Post-operative patient treatment included revision surgery, lysis of adhesions, diagnostic laparoscopy, and mesh removal.
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Manufacturer Narrative
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Additional info: b5, e1 (facility name, street 1, city, region, postal code), g1 (manufacturer name, mfr contact first name, last name, street 1, mfr city, region, country code, postal code, email, phone number), g3, 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 laparoscopic therapeutic treatment of a ventral hernia.It was reported that after implant, the patient experienced seroma, adhesions, nausea, diarrhea, chills, inflammation, tenderness, skin irritation, loss of appetite, loss of sleep, depression, chronic pain, abdominal pain, weak abdominal wall, recurrence, and suffering.Post-operative patient treatment included revision surgery, lysis of adhesions, diagnostic laparoscopy, and mesh removal.
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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 ventral hernia.It was reported that after implant, the patient experienced obstruction, scar tissue, allergic reaction, intestinal torsion, seroma, adhesions, nausea, diarrhea, chills, inflammation, tenderness, skin irritation, loss of appetite, loss of sleep, depression, chronic pain, abdominal pain, weak abdominal wall, recurrent incarcerated incisional hernia, and suffering.Post-operative patient treatment included medication, revision surgery, lysis of adhesions, extraction of small seroma, release of adherent bowel, diagnostic laparoscopy, mesh removal, and recurrent incarcerated incisional hernia repair with new mesh.
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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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