SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ COMPOSITE MESH; MESH, SURGICAL, POLYMERIC
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Model Number PCO9 |
Device Problems
Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abdominal Pain (1685); Abscess (1690); Purulent Discharge (1812); Erythema (1840); Unspecified Infection (1930); Pain (1994); Seroma (2069); Hernia (2240); Injury (2348); Impaired Healing (2378); Ascites (2596); 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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(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 hernia.It was reported that after the implant, the patient experienced seroma, chronic pain, suffering, a square/piece of mesh in left abdominal wall, abdominal pain, redness, open wound, fluctuance, abdominal fluid collection, mesh exposed, and purulent fluid.Post-operative patient treatment included revision surgeries, pain injections, mesh removal, hernia repair, drainage of seroma and fluid collection, loculations broken up, fluid and tissue debrided, and wound packed.
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Manufacturer Narrative
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Additional information: a4 (weight in lbs).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 therapeutic treatment of a ventral hernia.It was reported that after the implant, the patient experienced seroma, chronic pain, suffering, a square/piece of mesh in left abdominal wall, abdominal pain, redness, open wound, fluctuance, abdominal fluid collection, mesh exposed, purulent fluid, and recurrence.Post-operative patient treatment included revision surgeries, pain injections, mesh removal, hernia repair, drainage of seroma and fluid collection, loculations broken up, fluid and tissue debrided, and wound packed with kerlix.
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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 hernia.It was reported that after the implant, the patient experienced seroma, chronic pain, suffering, a square/piece of mesh in left abdominal wall, abdominal pain, redness, open wound, fluctuance, abdominal fluid collection, mesh exposed, purulent fluid, infection, abscess, and recurrence.Post-operative patient treatment included revision surgeries, wound exploration with drainage of subcutaneous fluid, pain injections, mesh removal, hernia repair, drainage of seroma and fluid collection, loculations broken up, fluid and tissue debrided, ultrasound test, and wound packed with kerlix.
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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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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 hernia.It was reported that after the implant, the patient experienced seroma, chronic pain, suffering, a square/piece of mesh in left abdominal wall, abdominal pain, redness, open wound, fluctuance, abdominal fluid collection, mesh exposed, purulent fluid, infection, abscess, and recurrence.Post-operative patient treatment included revision surgeries, pain injections, mesh removal, hernia repair, drainage of seroma and fluid collection, loculations broken up, fluid and tissue debrided, and wound packed with kerlix.
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Search Alerts/Recalls
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