SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ COMPOSITE MESH; MESH, SURGICAL, POLYMERIC
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Model Number PCO12 |
Device Problems
Material Erosion (1214); 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); Bacterial Infection (1735); Erosion (1750); Foreign Body Reaction (1868); Headache (1880); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Staphylococcus Aureus (2058); Scar Tissue (2060); Seroma (2069); Discharge (2225); Hernia (2240); Ulcer (2274); Injury (2348); Impaired Healing (2378); Blood Loss (2597); Fluid Discharge (2686); No Code Available (3191); 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 resulting in an unspecified adverse outcome.Product was used for therapeutic treatment.Preoperative and postoperative diagnosis was ventral incisional hernia.The procedure performed was laparoscopic repair of ventral, incisional hernia.The patient experienced removal or revision surgery resulting from complications from 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 a ventral incisional hernia.It was reported that after implant, the patient experienced recurrence, infection, granulation tissue with acute and chronic inflammation, abdominal wall abscess, mucoid drainage, wound with exposed mesh and open wound.Post-operative patient treatment included debridement of abdominal wall wound, mesh excision and wound vac placement, removal of prior mesh and placement of new cook biodesign 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 laparoscopic therapeutic treatment of a ventral incisional hernia.It was reported that after implant, the patient experienced recurrence, infection, (b)(6), granulation tissue with acute and chronic inflammation, bleeding gastric ulcer, abdominal wall abscess and abscesses that continued developing along the edges of the mesh, mucoid drainage, adhesions, wound with exposed mesh and open wound.Post-operative patient treatment included debridement of abdominal wall wound, mesh excision and wound vac placement, subtotal gastrectomy, removal of prior mesh and placement of new cook biodesign 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 a ventral incisional hernia.It was reported that after implant, the patient experienced recurrence, infection, (b)(6), granulation tissue with acute and chronic inflammation, bleeding gastric ulcer, abdominal wall abscess and abscesses that continued developing along the edges of the mesh, mucoid drainage, adhesions, wound with exposed mesh, pain, mesh erosion, scarification, mesh encapsulation, lack of adequate ingrowth, and open wound.Post-operative patient treatment included debridement of abdominal wall wound, mesh excision and wound vac placement, subtotal gastrectomy, removal of prior mesh and placement of new cook biodesign 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 laparoscopic therapeutic treatment of a ventral incisional hernia.It was reported that after implant, the patient experienced recurrence, infection, granulation tissue with acute and chronic inflammation, bleeding gastric ulcer, abdominal wall abscess and abscesses that continued developing along the edges of the mesh, mucoid drainage, adhesions, wound with exposed mesh, pain, mesh erosion, scarification, mesh encapsulation, lack of adequate ingrowth, methicillin sensitive staph aureus, and open wound.Post-operative patient treatment included debridement of abdominal wall wound, mesh excision and wound vac placement, subtotal gastrectomy, removal of prior mesh and placement of new cook biodesign mesh, i/d, lap lysis of adhesions, excisional debridement, kcl wound vacuum, and mucoid drainage.Relevant tests/laboratory data: on (b)(6) 2014: pathology report on abdominal abscess tissue showed granulation tissue with acute and chronic inflammation.On (b)(6) 2016: op note stated methicillin sensitive staph aureus from a previous i/d.
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Manufacturer Narrative
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Additional information: a5a, a5b, b5, b6, g1 (manufacturer name, first name, last name, street 1, city, region, postal code, email, phone).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.
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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 a ventral incisional hernia.It was reported that after implant, the patient experienced seroma, headaches, recurrence, infection, granulation tissue with acute and chronic inflammation, bleeding gastric ulcer, abdominal wall abscess and abscesses that continued developing along the edges of the mesh, mucoid drainage, adhesions, wound with exposed mesh, pain, mesh erosion, scarification, mesh encapsulation, lack of adequate ingrowth, methicillin sensitive staph aureus, and open wound.Post-operative patient treatment included medication, partial mesh excision, excised overlying scar, debridement of abdominal wall wound, incision and drainage of abscess, abdominal wound exploration, wound vac placement, subtotal gastrectomy, removal of prior mesh and placement of new cook biodesign mesh, id, lap lysis of adhesions, excisional debridement, kcl wound vacuum, and mucoid drainage.
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Manufacturer Narrative
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Additional info: a4, b5, b7, h6 (patient codes, imf code).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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