SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ COMPOSITE MESH; MESH, SURGICAL, POLYMERIC
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Model Number PCO9 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
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Patient Problems
Abscess (1690); Purulent Discharge (1812); Fever (1858); Foreign Body Reaction (1868); Unspecified Infection (1930); Necrosis (1971); Pain (1994); Perforation (2001); Hernia (2240); Ulcer (2274); Injury (2348); Impaired Healing (2378); Fluid Discharge (2686); Unspecified Tissue Injury (4559)
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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.It was reported that after a procedure where this device was implanted, the patient experienced pain and infected mesh.After the original procedure, additional potentially related procedures were performed, revision surgery.
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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 reducible incisional hernia in the right upper quadrant.It was reported that after a procedure where this device was implanted, the patient experienced pain and infected mesh.The mesh was removed 5 months after original implantation.
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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.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 reducible incisional hernia in the right upper quadrant.It was reported that after a procedure where this device was implanted, the patient experienced pain, open wound, abscess, infected mesh, foreign body reaction, purulent material, perforated ulcer, discharge, entire fascia necrotic, fever.Post-operative patient treatment included revision surgery, mesh removal, repair of hernia with mesh, incision and drainage of abscess, debridement of open wound, resection of portion of abdominal wall and reconstruction.
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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 reducible incisional hernia in the right upper quadrant.It was reported that after a procedure where this device was implanted, the patient experienced pain, open wound, abscess, and infected mesh.Post-operative patient treatment included revision surgery, mesh removal, repair of hernia with mesh, incision and drainage of abscess, and debridement of open wound.
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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.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 info: a4, b5, b7, d8, e1 (facility name, street, city, region, postal code), h6 (updated all codes, added patient codes, device code, and imf codes).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 reducible incisional hernia in the right upper quadrant.It was reported that after a procedure where this device was implanted, the patient experienced recurrence, pain, open wound, abscess, infected mesh, foreign body reaction, purulent material, perforated ulcer, discharge, entire fascia necrotic, fever.Post-operative patient treatment included revision surgery, mesh removal, repair of hernia with mesh, incision and drainage of abscess, exploratory laparotomy, lysis of adhesions, repair of duodenal ulcer, debridement of ulcer, debridement of open wound, resection of portion of abdominal wall and reconstruction.
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