SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ COMPOSITE MESH; MESH, SURGICAL, POLYMERIC
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Model Number PCO2015 |
Device Problems
Degraded (1153); Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abdominal Pain (1685); Adhesion(s) (1695); Purulent Discharge (1812); Fever (1858); Unspecified Infection (1930); Inflammation (1932); Muscle Weakness (1967); Necrosis (1971); Pain (1994); Tachycardia (2095); Hernia (2240); Discomfort (2330); Impaired Healing (2378); Obstruction/Occlusion (2422); Abdominal Distention (2601); Weight Changes (2607); Nodule (4551); Unspecified Tissue Injury (4559); Decreased Appetite (4569); 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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Concomitant product: sorbafix absorbable fixation system (product id: 0113080, lot number: dati0013) (b)(4).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 small bowel obstruction, infection, feculent/foul smelling drainage from wound, exposed mesh, non-healing open wound, calcified mesh, recurrence, abdominal pain, firm nodules, fever, mild tachycardia, necrosis, weight loss, loss of appetite, discomfort, subcutaneous mass, attenuation, and adhesions.Post-operative patient treatment included partial removal of mesh, full removal of mesh, wound vac, wound debridement, adhesiolysis, stamm gastrostomy tube placement in remnant stomach, peritoneal biopsy x3, mesenteric nodule biopsy x1, antibiotics, debridement of skin/subcutaneous tissue/muscle/fascia for necrotizing soft tissue infection, abdominal washout, abthera placement, placement of wittman patch, prolonged hospitalization, removal of wittman patch, removal of jp drain, abdominal washout, creation of bilateral myofascial flaps, closure of abdominal wall fascia, subcutaneous tissues packed, bilateral posterior component separation (transversus abdominis muscle flaps), removal of deep foreign bodies, muscle x 4, removal deep foreign bodies, peritoneum x 7, regional block (transversus abdominis plane block), bilateral with liposomal bupivacaine, adjacent tissue transfer, incisional vac, scar excision, subcutaneous mass resection, removal of tacks/sutures, and hernia repair with new 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 treatment of a ventral incisional hernia.It was reported that after implant, the patient experienced small bowel obstruction, infection, feculent/foul smelling drainage from wound, exposed mesh, non-healing open wound, calcified mesh, recurrence, abdominal pain, firm nodules, fever, mild tachycardia, necrosis, weight loss, loss of appetite, discomfort, subcutaneous mass, attenuation, chronic pain, mesh migration and adhesions.Post-operative patient treatment included partial removal of mesh, full removal of mesh, wound vac, wound debridement, adhesiolysis, stamm gastrostomy tube placement in remnant stomach, peritoneal biopsy x3, mesenteric nodule biopsy x1, antibiotics, debridement of skin/subcutaneous tissue/muscle/fascia for necrotizing soft tissue infection, abdominal washout, abthera placement, placement of wittman patch, prolonged hospitalization, removal of wittman patch, removal of jp drain, abdominal washout, creation of bilateral myofascial flaps, closure of abdominal wall fascia, subcutaneous tissues packed, bilateral posterior component separation (transversus abdominis muscle flaps), removal of deep foreign bodies, muscle x 4, removal deep foreign bodies, peritoneum x 7, regional block (transversus abdominis plane block), bilateral with liposomal bupivacaine, adjacent tissue transfer, incisional vac, scar excision, subcutaneous mass resection, removal of tacks/sutures, and hernia repair with new 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 treatment of a ventral incisional hernia.It was reported that after implant, the patient experienced bloating, constantly feeling full, acute kidney injury, inflammation, small bowel obstruction, infection, feculent/foul smelling drainage from wound, exposed mesh, non-healing open wound, calcified mesh, recurrence, abdominal pain, firm nodules, fever, mild tachycardia, necrosis, weight loss, loss of appetite, discomfort, subcutaneous mass, attenuation, chronic pain, mesh migration, and adhesions.Post-operative patient treatment included medications, revision of mesh, partial removal of mesh, full removal of mesh, wound vac, wound debridement, adhesiolysis, stamm gastrostomy tube placement in remnant stomach, peritoneal biopsy x3, mesenteric nodule biopsy x1, antibiotics, debridement of skin/subcutaneous tissue/muscle/fascia for necrotizing soft tissue infection, abdominal washout, abthera placement, placement of wittman patch, prolonged hospitalization, icu with ventilator use, removal of wittman patch, removal of jp drain, abdominal washout, creation of bilateral myofascial flaps, closure of abdominal wall fascia, subcutaneous tissues packed, bilateral posterior component separation (transversus abdominis muscle flaps), removal of deep foreign bodies, muscle x 4, removal deep foreign bodies, peritoneum x 7, regional block (transversus abdominis plane block), bilateral with liposomal bupivacaine, adjacent tissue transfer, incisional vac, scar excision, subcutaneous mass resection, removal of tacks/sutures, and hernia repair with new mesh.
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Manufacturer Narrative
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Additional info: b5, b7, g1, h6 (patient 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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