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)
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Patient Problems
Abdominal Pain (1685); Adhesion(s) (1695); Dyspnea (1816); Emotional Changes (1831); Low Blood Pressure/ Hypotension (1914); Hypoxia (1918); Unspecified Infection (1930); Inflammation (1932); Nausea (1970); Nerve Damage (1979); Pain (1994); Pneumothorax (2012); Seroma (2069); Thrombus (2101); Vomiting (2144); Burning Sensation (2146); Cramp(s) (2193); Hernia (2240); Discomfort (2330); Injury (2348); Impaired Healing (2378); Obstruction/Occlusion (2422); Abdominal Distention (2601); No Code Available (3191); Constipation (3274); Thrombosis/Thrombus (4440); Cramp(s) /Muscle Spasm(s) (4521); 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 underwent a laparoscopic incisional hernia repair with mesh on (b)(6) 2010.This was due to an incisional hernia, recurrent with small bowel obstruction.On (b)(6) 2015 she underwent surgery for the repair of recurrent incisional hernia with mesh.The patient experienced recurrence and chronic pain.
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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 an incisional hernia.It was reported that after implant, the patient experienced mental pain, disability, impairment, loss of enjoyment of life, defective mesh, recurrence, chronic pain, dense adhesions, nerve damage, metallic densities along anterior abdominal hernia, bowel obstruction, tenderness, bulge, abdominal pain, cramping, constipation, vomited, wadded up mesh, hypercarbic, slightly hypoxic, hypotensive, pneumothorax, blood clots, shortness of breath, burning feeling, costochondritis, and open wound.Post-operative patient treatment included revision, incisional excision, additional implants, wound vac, hospitalized, medications, nasogastric tube, abdominal reconstruction, bilateral posterior abdominis release, and myofascial medial advancement flaps, repair of diaphragm hernia, repair of bilateral inguinal hernia, chest tube inserted, and recurrence repairs.
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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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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 an incisional hernia.It was reported that after implant, the patient experienced recurrence, chronic pain, dense adhesions, nerve damage, metallic densities along anterior abdominal hernia, bowel obstruction, tenderness, bulge, abdominal pain, cramping, constipation, vomited, wadded up mesh, hypercarbic, slightly hypoxic, hypotensive, pneumothorax, blood clots, shortness of breath, burning feeling, costochondritis, and open wound.Post-operative patient treatment included revision, incisional excision, additional implants, wound vac, hospitalized, medications, nasogastric tube, abdominal reconstruction, bilateral posterior abdominis release, and myofascial medial advancement flaps, repair of diaphragm hernia, repair of bilateral inguinal hernia, chest tube inserted, and recurrence repairs.
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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 an incisional hernia.It was reported that after implant, the patient experienced recurrence, chronic pain, dense adhesions, nerve damage and open wound.Post-operative patient treatment included revision, incisional excision, additional implants, wound vac and recurrence repairs.
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Manufacturer Narrative
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Additional info: b5, h6 (patient 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.The product was used for laparoscopic therapeutic treatment of an incisional hernia.It was reported that after implant, the patient experienced infected mesh, seroma, small bowel incarceration, inflammation, nausea, vomiting, mental pain, disability, impairment, loss of enjoyment of life, defective mesh, recurrence, chronic pain, dense adhesions, nerve damage, metallic densities along anterior abdominal hernia, bowel obstruction, tenderness, bulge, abdominal pain, cramping, constipation, vomited, wadded up mesh, hypercarbic, slightly hypoxic, hypotensive, pneumothorax, blood clots, shortness of breath, burning feeling, costochondritis, and open wound.Post-operative patient treatment included abdominal wall reconstruction, ct scan, revision, incisional excision, additional implants, wound vac, hospitalized, medications, nasogastric tube, abdominal reconstruction, bilateral posterior abdominis release, and myofascial medial advancement flaps, repair of diaphragm hernia, repair of bilateral inguinal hernia, chest tube inserted, and recurrence repairs.
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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 an incisional hernia.It was reported that after implant, the patient experienced inflammation, nausea, vomiting, mental pain, disability, impairment, loss of enjoyment of life, defective mesh, recurrence, chronic pain, dense adhesions, nerve damage, metallic densities along anterior abdominal hernia, bowel obstruction, tenderness, bulge, abdominal pain, cramping, constipation, vomited, wadded up mesh, hypercarbic, slightly hypoxic, hypotensive, pneumothorax, blood clots, shortness of breath, burning feeling, costochondritis, and open wound.Post-operative patient treatment included ct scan, revision, incisional excision, additional implants, wound vac, hospitalized, medications, nasogastric tube, abdominal reconstruction, bilateral posterior abdominis release, and myofascial medial advancement flaps, repair of diaphragm hernia, repair of bilateral inguinal hernia, chest tube inserted, and recurrence repairs.
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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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