SOFRADIM PRODUCTION SAS MESH SOFRADIM- PARIETEX COMPOSITE MESH; MESH, SURGICAL, POLYMERIC
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Model Number PCO1510 |
Device Problems
Material Fragmentation (1261); 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
Erosion (1750); Unspecified Infection (1930); Ischemia (1942); Necrosis (1971); Pain (1994); Hernia (2240); Injury (2348); Impaired Healing (2378); 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 therapeutic treatment of a large epigastric incisional hernia.During the implant procedure, adhesions, a massive pannus, and two incisional hernias were noted.It was reported that after implant, the patient experienced chronic non-healing wound, free floating mesh, and necrotic tissue.Treatment provided for these conditions included surgical revision and necrotic tissue debridement in (b)(6) 2011, where free floating small pieces of mesh were noted in the wound.
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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 large epigastric incisional hernia.It was reported that after implant, the patient experienced recurrence, chronic non-healing wound, free floating mesh, infection, necrotic tissue, and ischemic tissue over mesh.Treatment provided for these conditions included surgical revision, necrotic tissue debridement, exploratory laparotomy, small bowel resection, retrieval of foreign body, sharp excision of subcutaneous tissue debridement, repair of hernia with mesh, acellular dermal allograft, and an umbilectomy.
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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 therapeutic treatment of a large epigastric incisional hernia.During the implant procedure, adhesions, a massive pannus, and two incisional hernias were noted.It was reported that after implant, the patient experienced recurrence, chronic non-healing wound, free floating mesh, infection, and necrotic tissue.Treatment provided for these conditions included surgical revision, necrotic tissue debridement, exploratory laparotomy, small bowel resection, retrieval of foreign body, sharp excision of subcutaneous tissue debridement, and repair of hernia with 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.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 large epigastric incisional hernia.It was reported that after implant, the patient experienced recurrence, chronic non-healing wound, free floating mesh, mesh migration, infection, necrotic tissue, pain, mesh erosion, and ischemic tissue over mesh.Treatment provided for these conditions included surgical revision, necrotic tissue debridement, exploratory laparotomy, small bowel resection, retrieval of foreign body, sharp excision of subcutaneous tissue debridement, wound debridement, repair of hernia with mesh, acellular dermal allograft, and an umbilectomy.
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Manufacturer Narrative
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Additional information: b5, d8, g3, h6 correction: e1(facility name, street 1, city, region and postal code), g1(mfr contact first name, last name, street 1, mfr city, region, postal code, email and phone number) 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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