SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ COMPOSITE MESH; MESH, SURGICAL, POLYMERIC
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Model Number PCO2520 |
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
Adhesion(s) (1695); Foreign Body Reaction (1868); Unspecified Infection (1930); Inflammation (1932); Laceration(s) (1946); Muscle Weakness (1967); Pain (1994); Perforation (2001); Scar Tissue (2060); Scarring (2061); Hernia (2240); Injury (2348); Obstruction/Occlusion (2422); No Code Available (3191); Constipation (3274); Thrombosis/Thrombus (4440); 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.The product was used for therapeutic treatment of a hernia.It was reported that after implant, the patient experienced an adverse outcome.
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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 hernia by laparoscopic repair.It was reported that after implant, the patient experienced recurrence, dense adhesions between mesh and bladder fundus mesh and appendix, lipoma, migration, scarring, deep vein thrombosis, pain, constipation, and rectus abdominal muscle diastasis.Post-operative patient treatment included revision, abdominal flap repair, removal of mesh, repair of recurrent hernias with additional meshes, lysis of adhesions, appendectomy, and anticoagulating medication.During revision surgery there was an inadvertent bladder laceration which required urologic surgical repair.
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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.Additional information: patient code: c64343(large lipoma, bladder laceration, deep vein thrombosis, rectus abdominal muscle diastasis).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 hernia by laparoscopic repair.It was reported that after implant, the patient experienced recurrence, dense adhesions between mesh and bladder fundus mesh and appendix, lipoma, migration, scarring, deep vein thrombosis, pain, constipation, rectus abdominal muscle diastasis, infection, mesh migration, inflammation, mesh encapsulation and lack of adequate ingrowth.Post-operative patient treatment included revision, abdominal flap repair, removal of mesh, repair of recurrent hernias with additional meshes, lysis of adhesions, appendectomy, and anticoagulating medication.During revision surgery there was an inadvertent bladder laceration which required urologic surgical repair.
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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, b7, g1, h6 (patient and health impact 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 therapeutic treatment of a ventral hernia by laparoscopic repair.It was reported that after implant, the patient experienced obstruction, perforation, recurrence, dense adhesions between mesh and bladder fundus mesh and appendix, lipoma, migration, scarring, deep vein thrombosis, pain, constipation, rectus abdominal muscle diastasis, infection, mesh migration, inflammation, mesh encapsulation, and lack of adequate ingrowth.Post-operative patient treatment included medication, revision, abdominal flap repair, removal of mesh, repair of recurrent hernias with additional meshes, lysis of adhesions, appendectomy, and anticoagulating medication.During revision surgery there was an inadvertent bladder laceration which required urologic surgical repair.
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Manufacturer Narrative
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Additional info: a1, a4, a5b, d4 (expiration date), & h4.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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