SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ COMPOSITE MESH; MESH, SURGICAL, POLYMERIC
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Model Number PCO2520 |
Device Problems
Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abscess (1690); Adhesion(s) (1695); Purulent Discharge (1812); Emotional Changes (1831); Fever (1858); Hematoma (1884); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Inflammation (1932); Nausea (1970); Pain (1994); Renal Failure (2041); Seroma (2069); Hernia (2240); Distress (2329); Injury (2348); Impaired Healing (2378); Obstruction/Occlusion (2422); Ascites (2596); Abdominal Distention (2601); Fluid Discharge (2686); No Code Available (3191); 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 chronic pain, recurrence of hernia, and dense adhesions.Treatment required included surgical revision of the mesh.
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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 an incisional hernia.It was reported that after implant, the patient experienced chronic pain, recurrence of hernia, infection of a cavity beneath the mesh filled with clot/pus, abscess, open wound, hematoma, fluid collections, gi distress, pain, nausea, fevers, hypotensions, decreased hematocrit, altered mental status, seroma, distention, renal failure, postop ileus, leukocytosis, mental pain, disability, impairment, loss of enjoyment of life, defective mesh, and dense adhesions.Post-operative patient treatment included surgical revision, adhesiolysis, explant of the mesh, implant of new mesh, transfusion of 4 units packed red blood cells, iv antibiotics, oxygen, diuresis, ng tube for drainage, pain medications, iv fluids, advair, aspiration of seroma, drain placed, and wound/hematoma evacuation.
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Manufacturer Narrative
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(b)(4).If information is provided in the future, a supplemental report will be issued.
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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 an incisional hernia.It was reported that after implant, the patient experienced chronic pain, recurrence of hernia, infection of a cavity beneath the mesh filled with clot/pus, abscess, open wound with hematoma, and dense adhesions.Treatment required included surgical revision, adhesiolysis, explant of the mesh, implant of new mesh, and wound/hematoma evacuation.
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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 an incisional hernia.It was reported that after implant, the patient experienced chronic pain, recurrence of hernia, infection of a cavity beneath the mesh filled with clot/pus, abscess, open wound, hematoma, fluid collections, gi distress, pain, nausea, fevers, hypotensions, decreased hematocrit, altered mental status, seroma, distention, renal failure, postop ileus, and dense adhesions.Post-operative patient treatment included surgical revision, adhesiolysis, explant of the mesh, implant of new mesh, transfusion of 4 units packed red blood cells, iv antibiotics, oxygen, diuresis, ng tube for drainage, pain medications, iv fluids, advair, aspiration of seroma, drain placed, and wound/hematoma evacuation.
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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.(b)(4).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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Event Description
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The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of an incisional hernia.It was reported that after implant, the patient experienced wound drainage, chronic pain, recurrence of hernia, infection of a cavity beneath the mesh filled with clot/pus, abscess, open wound, hematoma, fluid collections, gi distress, pain, nausea, fevers, hypotensions, decreased hematocrit, altered mental status, seroma, distention, renal failure, postop ileus, leukocytosis, mental pain, disability, impairment, loss of enjoyment of life, defective mesh, dense adhesions, abnormal levels of creatinine; white blood cells, inflammatory reaction.Post-operative patient treatment included debridement, surgical revision, adhesiolysis, explant of the mesh, implant of new meshes, transfusion of 4 units packed red blood cells, iv antibiotics, oxygen, diuresis, ng tube for drainage, pain medications, iv fluids, advair, aspiration of seroma, drain placed, wound/hematoma evacuation, ct scan.
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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 an incisional hernia.It was reported that after implant, the patient experienced chronic pain, recurrence of hernia, infection of a cavity beneath the mesh filled with clot/pus, abscess, open wound, hematoma, fluid collections, gi distress, pain, nausea, fevers, hypotensions, decreased hematocrit, altered mental status, seroma, distention, renal failure, postop ileus, leukocytosis, mental pain, disability, impairment, loss of enjoyment of life, defective mesh, dense adhesions, abnormal levels of creatinine; white blood cells, <(>&<)> inflammatory reaction.Post-operative patient treatment included surgical revision, adhesiolysis, explant of the mesh, implant of new mesh, transfusion of 4 units packed red blood cells, iv antibiotics, oxygen, diuresis, ng tube for drainage, pain medications, iv fluids, advair, aspiration of seroma, drain placed, wound/hematoma evacuation, <(>&<)> ct scan.
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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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