SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ COMPOSITE MESH; MESH, SURGICAL, POLYMERIC
|
Back to Search Results |
|
Model Number PCO12 |
Device Problems
Migration or Expulsion of Device (1395); Material Perforation (2205); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
|
Patient Problems
Abdominal Pain (1685); Adhesion(s) (1695); Foreign Body Reaction (1868); Headache (1880); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Internal Organ Perforation (1987); Pain (1994); Perforation (2001); Sepsis (2067); Seroma (2069); Vomiting (2144); Hernia (2240); Urinary Frequency (2275); Injury (2348); Obstruction/Occlusion (2422); Constipation (3274); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
|
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 a ventral hernia.It was reported that after implant, the patient experienced bowel obstruction and perforation, mesh folding, rejection of mesh, severe abdominal and groin pain, vomiting, and lack of bowel movement for one week.Post-operative patient treatment included removal of mesh and release of bowel obstruction surgery.
|
|
Manufacturer Narrative
|
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.If information is provided in the future, a supplemental report will be issued.
|
|
Manufacturer Narrative
|
Additional info: b5, d8, e1, g1, h6 (all codes; e2402: ileus with fecal impaction).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 a ventral hernia.It was reported that after implant, the patient experienced recurrence, adhesions, seroma, mesh migration, sepsis, ileus with fecal impaction, bowel obstruction and perforation, mesh folding, rejection of mesh, severe abdominal and groin pain, vomiting, and lack of bowel movement for one week.Post-operative patient treatment included removal of mesh, ct scan, and release of bowel obstruction surgery.
|
|
Manufacturer Narrative
|
Additional information: b2, b5, b7, h4, h6(patient codes), additional 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.
|
|
Event Description
|
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 implant, the patient experienced recurrence, adhesions, seroma, mesh migration, sepsis, bowel obstruction and perforation, mesh folding, severe abdominal and groin pain, vomiting, infection, inflammation, blood loss, abdominal pain, unable to sleep laying down, unable to walk without walker, headache, indigestion, urinary frequency.Post-operative patient treatment included removal of mesh, ct scan, and release of bowel obstruction surgery, 1 pelvic and 2 extrafascial, muscular closer, extensive lysis of adhesions, exploratory laparotomy, placement of drains, hernia repair with new mesh, medication.Relevant tests/laboratory data (b6): 16may2011: er- abdominal series showed some mild postoperative ileus with fecal impaction.18may2011: ct scan demonstrated small bowel obstruction secondary to incarcerated hernia in the right mid abdomen and possible umbilical hernia.
|
|
Search Alerts/Recalls
|
|
|