SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ COMPOSITE MESH; MESH, SURGICAL, POLYMERIC
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Model Number PCO2520 |
Device Problems
Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abscess (1690); Adhesion(s) (1695); Fistula (1862); Foreign Body Reaction (1868); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Seroma (2069); Hernia (2240); Obstruction/Occlusion (2422); Abdominal Distention (2601); Cramp(s) /Muscle Spasm(s) (4521); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); 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: unknown protack (lot# unknown).(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 incisional hernia.It was reported that after the implant, the patient experienced abscess, infection/infected mesh, hernia recurrence, inflamed fibroadipose tissue, bile stained mesh, hemorrhage, inflammation, transmural defects, foreign body giant cell reaction, edema, ingrowth of mesh to bowel, adhesions, small bowel obstruction, and mesh migration.Post-operative patient treatment included revision surgery, removal of mesh and tacks, wound vac, placement of drains, debridement and drainage of abscess, hernia repair with mesh, and small bowel resection with anastomosis.
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Manufacturer Narrative
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Additional information: b5, g3, 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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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 incisional hernia.It was reported that after the implant, the patient experienced abscess, infection/infected mesh, hernia recurrence, inflamed fibroadipose tissue, bile stained mesh, hemorrhage, inflammation, transmural defects, foreign body giant cell reaction, edema, ingrowth of mesh to bowel, adhesions, small bowel obstruction, pain and mesh migration.Post-operative patient treatment included revision surgery, removal of mesh and tacks, wound vac, placement of drains, debridement and drainage of abscess, hernia repair with mesh, and small bowel resection with anastomosis.
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Manufacturer Narrative
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Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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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 incisional hernia.It was reported that after the implant, the patient experienced abscess, infection/infected mesh, hernia recurrence, inflamed fibroadipose tissue, bile stained mesh, hemorrhage, inflammation, transmural defects, foreign body giant cell reaction, edema, ingrowth of mesh to bowel, adhesions, small bowel obstruction, pain, mesh migration, fistula, seroma, pain while lifting, cramping, bloating.Post-operative patient treatment included revision surgery, removal of mesh and tacks, wound vac, placement of drains, debridement and drainage of abscess, hernia repair with mesh, small bowel resection with anastomosis, portion of small bowel removed, drainage of seroma, wound vac, medication.
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