SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ COMPOSITE MESH; MESH, SURGICAL, POLYMERIC
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Model Number PCO12 |
Device Problems
Defective Device (2588); Material Deformation (2976); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
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Patient Problems
Abdominal Pain (1685); Adhesion(s) (1695); Erosion (1750); Emotional Changes (1831); Foreign Body Reaction (1868); Hematoma (1884); Hemorrhage/Bleeding (1888); Muscle Weakness (1967); Pain (1994); Seroma (2069); Swelling (2091); Urinary Retention (2119); Urinary Tract Infection (2120); Hernia (2240); Discomfort (2330); Injury (2348); Hematuria (2558); Blood Loss (2597); Abdominal Distention (2601); Dysuria (2684); Foreign Body In Patient (2687); No Code Available (3191); Constipation (3274); 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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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 a procedure where this device was implanted, the patient experienced chronic pain, adhesions, excision.After treatment, the patient experienced removal.
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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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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 laparoscopic therapeutic treatment of an incisional hernia.It was reported that after implant, the patient experienced chronic pain, adhesions, mesh erosion into viscera, hematuria, uterine indentation, distention, seroma, rectus diastasis, thickening of anterior bladder wall, induration of the prevesicle fat, hematoma, urinary tract infection, blood loss, abdominal pain, swelling, constipation, difficulty urinating, foreign body in bladder, bulging, discomfort, thickening of appendix, recurrence, mental pain, injury, disability, impairment, loss of enjoyment of life, and defective mesh.Post-operative patient treatment included revision surgery, repair of hernia with mesh, antibiotics, daily straight catheterization, self-cath routinely for almost a year, and excision.
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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 an incisional hernia.It was reported that after implant, the patient experienced chronic pain, adhesions, mesh erosion into viscera, and recurrence.Post-operative patient treatment included revision surgery, repair of hernia with mesh, and excision.
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Manufacturer Narrative
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Correction: h6(added patient 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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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 laparoscopic therapeutic treatment of an incisional hernia.It was reported that after implant, the patient experienced chronic pain, adhesions, mesh erosion into viscera, hematuria, uterine indentation, distention, seroma, rectus diastasis, thickening of anterior bladder wall, induration of the prevesicle fat, hematoma, urinary tract infection, blood loss, abdominal pain, swelling, constipation, difficulty urinating, foreign body in bladder, bulging, discomfort, thickening of appendix, and recurrence.Post-operative patient treatment included revision surgery, repair of hernia with mesh, antibiotics, daily straight catheterization, self-cath routinely for almost a year, and excision.
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Manufacturer Narrative
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Correction: h6 (removed 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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Manufacturer Narrative
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Additional info: d4 (expiration date), h6 (device 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.
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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 laparoscopic therapeutic treatment of an incisional hernia.It was reported that after implant, the patient experienced chronic pain, adhesions, mesh erosion into viscera, hematuria, uterine indentation, distention, seroma, rectus diastasis, thickening of anterior bladder wall, induration of the prevesicle fat, hematoma, urinary tract infection, blood loss, abdominal pain, swelling, constipation, difficulty urinating, foreign body in bladder, bulging, discomfort, thickening of appendix, recurrence, mental pain, injury, disability, impairment, loss of enjoyment of life, defective mesh, mesh was bulging through midpoint of the abdominal wall.Post-operative patient treatment included revision surgery, repair of hernia with mesh, antibiotics, daily straight catheterization, self-cath routinely for almost a year, and excision.
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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 laparoscopic therapeutic treatment of an incisional hernia.It was reported that after implant, the patient experienced bladder dysfunction, chronic pain, adhesions, mesh erosion into viscera, hematuria, uterine indentation, distention, seroma, rectus diastasis, thickening of anterior bladder wall, induration of the prevesicle fat, hematoma, urinary tract infection, blood loss, abdominal pain, swelling, constipation, difficulty urinating, foreign body in bladder, bulging, discomfort, thickening of appendix, recurrence, mental pain, injury, disability, impairment, loss of enjoyment of life, defective mesh, mesh was bulging through midpoint of the abdominal wall.Post-operative patient treatment included ct scan, cystoscopy, revision surgery, repair of hernia with mesh, antibiotics, daily straight catheterization, self-cath routinely for almost a year, and mesh excision.
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Manufacturer Narrative
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Additional info: b5, h6 (imf code, updated ime e2402 to include: "bladder dysfunction").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 laparoscopic therapeutic treatment of an incisional hernia.It was reported that after implant, the patient experienced bladder dysfunction, chronic pain, adhesions, mesh erosion into viscera, hematuria, uterine indentation, distention, seroma, rectus diastasis, thickening of anterior bladder wall, induration of the prevesical fat, hematoma, urinary tract infection, blood loss, abdominal pain, swelling, constipation, difficulty urinating, foreign body in bladder, bulging, discomfort, thickening of appendix, recurrence, mental pain, injury, disability, impairment, loss of enjoyment of life, defective mesh, & mesh was bulging through midpoint of the abdominal wall.Post-operative patient treatment included ct scan, cystoscopy, revision surgery, repair of hernia with mesh, antibiotics, exploratory lap, partial resection of mesh, daily straight catheterization, self-cath routinely for almost a year, and mesh excision.
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