SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ COMPOSITE MESH; MESH, SURGICAL, POLYMERIC
|
Back to Search Results |
|
Model Number PCO2520OS |
Device Problems
Material Erosion (1214); Migration or Expulsion of Device (1395); Product Quality Problem (1506); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
|
Patient Problems
Adhesion(s) (1695); Erosion (1750); Laceration(s) (1946); Pain (1994); Perforation (2001); Scar Tissue (2060); Scarring (2061); Cramp(s) (2193); Discharge (2225); Hernia (2240); Discomfort (2330); Injury (2348); Obstruction/Occlusion (2422); Fluid Discharge (2686); Cramp(s) /Muscle Spasm(s) (4521); Unspecified Tissue Injury (4559)
|
Event Type
Injury
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of an incarcerated incisional hernia.It was reported that after implant, the patient experienced recurrence of an incisional hernia that was incarcerated and painful, erosion, adhesions, loops of small bowel adherent to the mesh, and wrinkled mesh causing bowel obstruction.Treatment for these conditions included surgical revision of the mesh, lysis of adhesions, resection of loops of small bowel adherent to mesh, hernia repair with sutures, and later explant of the mesh.
|
|
Manufacturer Narrative
|
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.
|
|
Event Description
|
The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of an incarcerated incisional hernia.It was reported that after implant, the patient experienced recurrence of an incarcerated painful incisional hernia, laceration to bowel, adhesions, loops of small bowel adherent to the mesh (erosion), and wrinkled migrating mesh causing bowel obstruction.Treatment for these conditions included surgical revision of the mesh, lysis of adhesions, resection of loops of small bowel adherent to mesh, hernia repair with sutures, and later explant of the mesh.
|
|
Manufacturer Narrative
|
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.
|
|
Event Description
|
The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of an incarcerated incisional hernia.It was reported that after implant, the patient experienced recurrence of an incarcerated painful incisional hernia, laceration to bowel, adhesions, cramping, discomfort, scar, peritoneal wall oozing, loops of small bowel adherent to the mesh (erosion), and wrinkled migrating mesh causing bowel obstruction.Treatment for these conditions included surgical revision of the mesh, lysis of adhesions, resection of loops of small bowel adherent to mesh, excision of scar, hernia repair with sutures, and later explant of the mesh.Relevant tests/laboratory data, including dates (b6) 25 feb 2016: pathology report- tan mesh with adherent spiral shaped metal fragments.
|
|
Manufacturer Narrative
|
Additional information: b5, b6, e1 (facility name, street 1, city, region, postal code), g1, 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.
|
|
Event Description
|
The patient¿s attorney alleged a deficiency against the device.The product was used for laparoscopic therapeutic treatment of an in carcerated incisional hernia.It was reported that after implant, the patient experienced recurrence of an incarcerated painful incisional hernia, laceration to bowel, adhesions, cramping, discomfort, scar, peritoneal wall oozing, loops of small bowel adherent to the mesh (erosion), colon adherent to mesh, mesh eroded into bowel, and wrinkled migrating mesh causing bowel obstruction.Post-operative patient treatment for these conditions included surgical revision of the mesh, lysis of adhesions, resection of loops of small bowel adherent to mesh, reconstruction of bowel, excision of scar, multiple bowel resections, hernia repair with sutures, enterotomy, and later explant of the mesh.
|
|
Manufacturer Narrative
|
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.
|
|
Event Description
|
The patient¿s attorney alleged a deficiency against the device.The product was used for laparoscopic therapeutic treatment of an incarcerated incisional hernia.It was reported that after implant, the patient experienced recurrence of an incarcerated painful incisional hernia, laceration to bowel, adhesions, cramping, discomfort, scar, peritoneal wall oozing, loops of small bowel adherent to the mesh (erosion), colon adherent to mesh, mesh eroded into bowel, wrinkled migrating mesh causing bowel obstruction, bowel serosal tear, & perforation.Post-operative patient treatment for these conditions included surgical revision of the mesh, lysis of adhesions, resection of loops of small bowel adherent to mesh, reconstruction of bowel, excision of scar, multiple bowel resections, hernia repair with sutures, enterotomy, hernia repair with mesh and later explant of the mesh.Relevant tests/laboratory data, including dates (b)(6) 2016: pathology report- tan mesh with adherent spiral shaped metal fragments.
|
|
Search Alerts/Recalls
|
|
|