SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ COMPOSITE MESH; MESH, SURGICAL, POLYMERIC
|
Back to Search Results |
|
Model Number TET3030 |
Device Problems
Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
|
Patient Problems
Wound Dehiscence (1154); Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Erosion (1750); Purulent Discharge (1812); Foreign Body Reaction (1868); Unspecified Infection (1930); Inflammation (1932); Nausea (1970); Staphylococcus Aureus (2058); Scar Tissue (2060); Discharge (2225); Excessive Tear Production (2235); Hernia (2240); Injury (2348); Impaired Healing (2378); Obstruction/Occlusion (2422); Ascites (2596); Abdominal Distention (2601); Fibrosis (3167); No Code Available (3191)
|
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 umbilical hernia.It was reported that after implant, the patient experienced recurrence, numerous adhesions, old mesh incorporated some of scar tissue, subacute fascial wound dehiscence with exposed viscera, right edge of mesh had pulled off of fascia and exposed bowel and mesentery at periumbilical wound, dense abdominal wall adhesions where the bowel had subacutely eviscerated, dense intraabdominal adhesions, serosal tears, mesh had odor and foul-smelling, bowel leak from a distal jejunal enterotomy with significant succus in abdomen, old incorporated mesh that was seeding the sinus tract, infection, ascites, abscess, and purulent discharge.Post-operative patient treatment included recurrent incarcerated incisional hernia repair with mesh, incarcerated omentum was reduced, excised bulk of the old mesh, removal of old infected mesh, incarcerated tissue was reduced, extensive lysis of adhesions required to free anterior abdominal wall and mobilize small bowel off surgical site and mesh, repair to serosal tears, segmental small bowel resection, debridement of anterior abdominal wall, excision of intraperitoneal and anterior abdominal wall mesh, vac dressing applied, abdominal washout, abdominal wall closure with mesh, abdominal re-exploration for postoperative sepsis, evacuated turbid fluid sitting in central lower abdomen, incision and drainage of right retroperitoneal abscess as well as thick, tan, purulent fluid was obtained and lastly, ventral/incisional hernia repair with 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.Additional information: description of event or problem, explant date, premarket identification, adverse event problem.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 umbilical hernia.It was reported that after implant, the patient experienced recurrence, numerous adhesions, mesh erosion into viscera, open wound, old mesh incorporated some of scar tissue, subacute fascial wound dehiscence with exposed viscera, right edge of mesh had pulled off of fascia and exposed bowel and mesentery at periumbilical wound, dense abdominal wall adhesions where the bowel had subacutely eviscerated, dense intraabdominal adhesions, serosal tears, mesh had odor and foul-smelling, bowel leak from a distal jejunal enterotomy with significant succus in abdomen, old incorporated mesh that was seeding the sinus tract, infection, ascites, abscess, and purulent discharge.Post-operative patient treatment included recurrent incarcerated incisional hernia repair with mesh, incarcerated omentum was reduced, excised bulk of the old mesh, removal of old infected mesh, incarcerated tissue was reduced, extensive lysis of adhesions required to free anterior abdominal wall and mobilize small bowel off surgical site and mesh, repair to serosal tears, segmental small bowel resection, debridement of anterior abdominal wall, excision of intraperitoneal and anterior abdominal wall mesh, vac dressing applied, abdominal washout, abdominal wall closure with mesh, abdominal re-exploration for postoperative sepsis, evacuated turbid fluid sitting in central lower abdomen, incision and drainage of right retroperitoneal abscess as well as thick, tan, purulent fluid was obtained and lastly, ventral/incisional hernia repair with mesh.
|
|
Event Description
|
The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of an incarcerated umbilical hernia.It was reported that after implant, the patient experienced recurrence, adhesions, mesh erosion into viscera, open wound, scar tissue, subacute fascial wound dehiscence, right edge of mesh had pulled off of fascia and exposed bowel and mesentery at periumbilical wound, bowel had subacutely eviscerated, serosal tears, significant succus in abdomen, sinus tract, infection, ascites, abscess, staphylococcus epidermidis, staphylococcus aureus, candida dubliniensis, candida krusei, nausea, feculent drainage, fibrosis, inflammation, distention, obstruction, foreign body reaction, and purulent discharge.Post-operative patient treatment included recurrent incarcerated incisional hernia repair with mesh, incarcerated omentum was reduced, excised bulk of the old mesh, removal of old infected mesh, incarcerated tissue was reduced, extensive lysis of adhesions required to free anterior abdominal wall and mobilize small bowel off surgical site and mesh, repair to serosal tears, segmental small bowel resection, debridement of anterior abdominal wall, excision of intraperitoneal and anterior abdominal wall mesh, vac dressing applied, abdominal washout, abdominal wall closure with mesh, abdominal re-exploration for postoperative sepsis, evacuated turbid fluid sitting in central lower abdomen, incision and drainage of right retroperitoneal abscess as well as thick, tan, purulent fluid was obtained and lastly, ventral/incisional hernia repair with 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.
|
|
Search Alerts/Recalls
|
|
|