SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ COMPOSITE MESH; MESH, SURGICAL, POLYMERIC
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Model Number PCO2015 |
Device Problems
Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Foreign Body Reaction (1868); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Staphylococcus Aureus (2058); Hernia (2240); Injury (2348); Impaired Healing (2378); No Code Available (3191); Nodule (4551); 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 was reported that after a procedure where this device was implanted, the patient experienced multiple surgical revisions and infection.After treatment, the patient experienced revision surgery.
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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 a procedure where this device was implanted, the patient experienced recurrence, abscess, mesh migration, open wound, infection.After treatment, the patient experienced revision surgery, repair of hernia with mesh, drainage of abdominal wall abscess, excision of infected mesh, exploration and debridement of abdominal wound, component separation, and wound vac.
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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 a procedure where this device was implanted, the patient experienced recurrence, abscess, mesh migration, open wound, infection, elevated white blood cell count, foreign body giant cells and foamy microphages.After treatment, the patient experienced revision surgery, repair of hernia with mesh, drainage of abdominal wall abscess, excision of infected mesh, exploration and debridement of abdominal wound, component separation, and wound vac.
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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: description of event or problem, test/laboratory data, other relevant history, date received by mfr, evaluation 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 laparoscopic therapeutic treatment of a ventral incisional hernia.It was reported that after implant, the patient experienced recurrence, abscess, mesh migration, open wound, infection, elevated white blood cell count, foreign body giant cells, foamy microphages, right-sided abdominal lump for 10 days, hospital admission, sinus tract, persistent inflammation, adhesions, right abdominal wall pain and staph infection.Post-operative patient treatment included revision surgery, multiple repairs of hernia with additional mesh, drainage of abdominal wall abscess, excision of infected mesh, exploration and debridement of abdominal wound, component separation, percutaneous drainage under ultrasound, right transversus abdominis plane block, trigger point injection, intercostal nerve blocks, thoric epidural as well as wound vac.
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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: b2 (hospitalization ticked), b5, b7, d4 (expiration date), d7, g4, h6.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 information: b5, d8, e1 (facility name, street 1, city, region, postal code), g1 (mfr contact first name, last name, street 1, mfr city, region, postal code, email, phone number), g3, h6 h6 patient codes - e2402 (high wbc count, foamy microphages, sinus tract).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 laparoscopic therapeutic treatment of a ventral incisional hernia.It was reported that after implant, the patient experienced recurrence, abscess, mesh migration, open wound, infection, pain, elevated white blood cell count, foreign body giant cells, foamy microphages, right-sided abdominal lump for 10 days, hospital admission, sinus tract, persistent inflammation, adhesions, right abdominal wall pain and staph infection.Post-operative patient treatment included revision surgery, multiple repairs of hernia with additional mesh, drainage of abdominal wall abscess, excision of infected mesh, exploration and debridement of abdominal wound, component separation, percutaneous drainage under ultrasound, right transversus abdominis plane block, trigger point injection, abdominal wall reconstruction, intercostal nerve blocks, thoric epidural as well as wound vac.
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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 suffering, recurrence, abscess, mesh migration, open wound, infection, pain, elevated white blood cell count, foreign body giant cells, foamy microphages, right-sided abdominal lump for 10 days, hospital admission, sinus tract, persistent inflammation, adhesions, right abdominal wall pain and staph infection.Post-operative patient treatment included medication, ct scan, revision surgery, multiple repairs of hernia with additional mesh, drainage of abdominal wall abscess, excision of infected mesh, exploration and debridement of abdominal wound, component separation, percutaneous drainage under ultrasound, right transversus abdominis plane block, trigger point injection, abdominal wall reconstruction, intercostal nerve blocks, thoric epidural as well as wound vac.
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Manufacturer Narrative
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Additional info: a4, b5, b7, g1, g3, h6 (added imf 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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