SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ COMPOSITE MESH; MESH, SURGICAL, POLYMERIC
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Model Number PCO15 |
Device Problems
Material Erosion (1214); Migration or Expulsion of Device (1395); Product Quality Problem (1506); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
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Patient Problems
Abscess (1690); Adhesion(s) (1695); Erosion (1750); Cellulitis (1768); Diarrhea (1811); Fistula (1862); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Inflammation (1932); Ischemia (1942); Nausea (1970); Necrosis (1971); Pain (1994); Scar Tissue (2060); Hernia (2240); Injury (2348); Obstruction/Occlusion (2422); No Code Available (3191); 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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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 resulting in an unspecified adverse outcome.Product was used for therapeutic treatment.The patient underwent a laparoscopic incisional hernia repair.She had revision surgery 6 years and 3 months post-surgery.The patient underwent a laparoscopic repair hernia umbilical/ventral and incisional.The patient also underwent a exploratory laparotomy with reduction of suspected hernia and coverage with mesh.The patient underwent an incisional hernia repair with removal of infected mesh.The patient experienced multiple additional surgery, adhesions, infection, mesh removal, recurrence and revision.
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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 incisional hernia repair.The patient experienced additional surgery, adhesions, infection, nausea, fistula, inflammation, necrosis, serositis, intermittent diarrhea, scar tissue, sinus tracts, recurrence and revision surgery ((b)(6) 2012).
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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 laparoscopic treatment of incarcerated ventral hernia.It was reported that after implant the patient experienced pain, nausea, intermittent diarrhea, ischemia, elevated lactate, adhesions, infection, fistula, inflammation, necrosis, serositis, scar tissue, sinus tracts, mesh erosion into viscera, brown/stained mesh, recurrence, foreign material and giant cell reaction, and wad of old mesh that was grossly infected with suture material.Post-operative patient treatment included revision surgery, repair of hernia, exploratory laparotomy with fistula takedown, small bowel resection, fistula tract, and removal of infected 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 laparoscopic therapeutic treatment of incisional hernia repair.The patient experienced adhesions, infection, nausea, fistula, inflammation, necrosis, serositis, intermittent diarrhea, scar tissue, sinus tracts, mesh erosion into bowel, and mesh was brown/stained.And recurrence.Post-operative patient treatment included revision surgery, repair of hernia with mesh, exploratory laparotomy with fistula takedown, small bowel resection, and removal infected mesh.
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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 incisional hernia repair.The patient experienced adhesions, infection, nausea, fistula, inflammation, necrosis, serositis, intermittent diarrhea, scar tissue, sinus tracts, mesh erosion and recurrence.Post-operative patient treatment included revision surgery, repair of hernia with mesh, exploratory laparotomy with fistula takedown, small bowel resection, and removal infected 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 incisional hernia repair.The patient experienced adhesions, infection, nausea, fistula, inflammation, necrosis, serositis, intermittent diarrhea, scar tissue, sinus tracts, and recurrence.Post-operative patient treatment included revision surgery, repair of hernia with mesh, exploratory laparotomy with fistula takedown, small bowel resection, and removal infected 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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Event Description
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The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic laparoscopic treatment of incarcerated ventral hernia.It was reported that after implant the patient experienced obstruction, abscess, cellulitis, allergic reaction, meshoma/balling, pain, nausea, intermittent diarrhea, ischemia, elevated lactate, adhesions, infection, fistula, inflammation, necrosis, serositis, scar tissue, sinus tracts, mesh erosion into viscera, brown/stained mesh, recurrence, foreign material and giant cell reaction, and wad of old mesh that was grossly infected with suture material.Post-operative patient treatment included hernia repair with new mesh, medication, bowel removal, reduction of hernia, incision and drainage of wound, revision surgery, repair of hernia, exploratory laparotomy with fistula takedown, small bowel resection, fistula tract, and removal of infected 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 laparoscopic treatment of incarcerated ventral hernia.It was reported that after implant the patient experienced obstruction, abscess, cellulitis, allergic reaction, meshoma/balling, pain, nausea, intermittent diarrhea, ischemia, elevated lactate, adhesions, infection, fistula, inflammation, necrosis, serositis, scar tissue, sinus tracts, mesh erosion into viscera, brown/stained mesh, recurrence, foreign material and giant cell reaction, and wad of old mesh that was grossly infected with suture material.Post-operative patient treatment included medication, bowel removal, reduction of hernia, incision and drainage of wound, revision surgery, repair of hernia, exploratory laparotomy with fistula takedown, small bowel resection, fistula tract, and removal of infected mesh.
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Manufacturer Narrative
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Additional info: a4, b5, b7, e1 (facility name, street, city, region, postal code), e3, e4 (email), g1, g3, h6 (updated patient codes, ime e2402: "allergic reaction, serositis, elevated lactate, sinus tracts").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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