|
Model Number UNKNOWN PARIETEX |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Adhesion(s) (1695); Cyst(s) (1800); Fistula (1862); Hematoma (1884); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Scarring (2061); Sepsis (2067); Hernia (2240); Injury (2348); Obstruction/Occlusion (2422); Ascites (2596); Fibrosis (3167)
|
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 ventral hernia.It was reported that after implant, the patient experienced scarring, adhesions, infected mesh, attached scant fibroconnective tissue and adipose tissue with mild chronic inflammation and fibrosis, and a damaged/kinked 20cm segment of small bowel with 3 enterocutaneous fistulas.Post operative treatment included reopening of the vertical midline incision scar and dissection to the level of the fascia, hernia sac that was dissected free from the surrounding connective tissue, omentum that was removed from adhesions and returned to peritoneal cavity, transection of bowel and stapler used across mesentery below the bowel, mesh revision surgery, and an end-to-end enterroenterostomy done in two layers.
|
|
Manufacturer Narrative
|
Correction: evaluation 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 therapeutic treatment of an incarcerated ventral hernia.It was reported that after implant, the patient experienced recurrence, scarring, fluid collection, cyst, hematoma, necrotic fat, adhesions, abdominal wall sepsis, infected mesh, attached scant fibroconnective tissue and adipose tissue with mild chronic inflammation and fibrosis, and a damaged/kinked 20cm segment of small bowel, multiple enterocutaneous fistulas, and extensive scarring.Post operative treatment included reopening of the vertical midline incision scar and dissection to the level of the fascia, hernia sac that was dissected free from the surrounding connective tissue, omentum that was removed from adhesions and returned to peritoneal cavity, transection of bowel and stapler used across mesentery below the bowel, drainage of fluid collection, excision of cyst wall, evacuation of hematoma, removal of infected mesh, take down of fistula, small bowel resection, repair of hernia with mesh, and an end-to-end enteroenterostomy done in two layers.
|
|
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 ventral hernia.It was reported that after implant, the patient experienced recurrence, scarring, fluid collection, cyst, hematoma, adhesions, infected mesh, attached scant fibroconnective tissue and adipose tissue with mild chronic inflammation and fibrosis, and a damaged/kinked 20cm segment of small bowel, multiple enterocutaneous fistulas.Post operative treatment included reopening of the vertical midline incision scar and dissection to the level of the fascia, hernia sac that was dissected free from the surrounding connective tissue, omentum that was removed from adhesions and returned to peritoneal cavity, transection of bowel and stapler used across mesentery below the bowel, drainage of fluid collection, excision of cyst wall, evacuation of hematoma, removal of infected mesh, take down of fistula, small bowel resection, repair of hernia with mesh, and an end-to-end enterroenterostomy done in two layers.
|
|
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
|
|
|