SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ COMPOSITE MESH; MESH, SURGICAL, POLYMERIC
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Model Number PCO20 |
Device Problems
Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Cellulitis (1768); Diarrhea (1811); Purulent Discharge (1812); Emotional Changes (1831); Fistula (1862); Foreign Body Reaction (1868); Granuloma (1876); Unspecified Infection (1930); Inflammation (1932); Nausea (1970); Pain (1994); Scar Tissue (2060); Seroma (2069); Vomiting (2144); Discharge (2225); Hernia (2240); Injury (2348); Impaired Healing (2378); Obstruction/Occlusion (2422); Fluid Discharge (2686); Fibrosis (3167); 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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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, small bowel obstruction, small bowel resection, adhesions, draining sinus tract, fistula, inflammatory granuloma and infection.Post-operative patient treatment included additional surgical intervention.
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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 laparoscopic treatment of a recurrent ventral hernia.It was reported that after implant, the patient experienced recurrence, open wound, chronic pain, small bowel obstruction, adhesions, draining sinus tract, fistula, inflammatory granuloma, infection, nausea, vomiting, abdominal pain, postoperative ileus, postoperative seroma, fibrosis, diarrhea, wound producing pus, and foreign body granulomatous response.Post-operative patient treatment included incisional hernia revision, small bowel resection, lysis of adhesions, wound exploration with removal of foreign body, wound vac, excision and mesh explant.
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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 a recurrent ventral hernia.It was reported that after implant, the patient experienced recurrence, open wound, chronic pain, small bowel obstruction, adhesions, draining sinus tract, fistula, inflammatory granuloma, infection, nausea, vomiting, abdominal pain, postoperative ileus, postoperative seroma, fibrosis, diarrhea, wound producing pus, mental pain, disability, impairment, loss of enjoyment of life, defective mesh, and foreign body granulomatous response.Post-operative patient treatment included incisional hernia revision, small bowel resection, lysis of adhesions, wound exploration with removal of foreign body, wound vac, excision and mesh explant.
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Manufacturer Narrative
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Additional info: b5, b7, h4, 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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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 a recurrent ventral hernia.It was reported that after implant, the patient experienced abscess, cellulitis, recurrence, open wound, chronic pain, small bowel obstruction, adhesions, draining sinus tract, fistula, inflammatory granuloma, infection, nausea, vomiting, abdominal pain, postoperative ileus, postoperative seroma, fibrosis, diarrhea, wound producing pus, mental pain, disability, impairment, loss of enjoyment of life, defective mesh, and foreign body granulomatous response.Post-operative patient treatment included ct scan, incisional hernia revision, small bowel resection, lysis of adhesions, wound exploration with removal of foreign body, wound vac, excision and mesh explant.
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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 a recurrent ventral hernia.It was reported that after implant, the patient experienced induration, scar tissue, abscess, cellulitis, recurrence, open wound, chronic pain, small bowel obstruction, adhesions, draining sinus tract, fistula, inflammatory granuloma, infection, nausea, vomiting, abdominal pain, postoperative ileus, postoperative seroma, fibrosis, diarrhea, wound producing pus, mental pain, disability, impairment, loss of enjoyment of life, defective mesh, and foreign body granulomatous response.Post-operative patient treatment included ct scan, incisional hernia revision, mesh revision, small bowel resection, lysis of adhesions, wound exploration with removal of foreign body, wound vac, excision and mesh explant.
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