|
Model Number PCO2520X |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Abscess (1690); Adhesion(s) (1695); Foreign Body Reaction (1868); Granuloma (1876); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Scar Tissue (2060); Scarring (2061); Sepsis (2067); Seroma (2069); Hernia (2240); Injury (2348); No Code Available (3191); Nodule (4551); 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 an acute ventral incisional hernia.It was reported that after implant, the patient experienced infection, adhesions, seroma, large clump of adipose tissue and recurrence.Post-operative patient treatment included revision surgery, exploration and reduction of recurrent incisional hernia, lysis of adhesions, excision of infected prosthetic mesh, redo incisional hernia repair with biologic mesh, bilateral component separations, debridement, drainage of massive recurrent abdominal wall seroma with sclerosis of the seroma cavity and anterior surface of cavity was excised.
|
|
Manufacturer Narrative
|
Additional information: a4, b5, b7, g4, h6 h6:patient code-c64343(large clump of adipose tissue) 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 acute ventral i ncisional hernia.It was reported that after implant, the patient experienced infection, adhesions, scarring, seroma, large clump of adipose tissue and recurrence.Post-operative patient treatment included revision surgery, exploration and reduction of recurrent i ncisional hernia, lysis of adhesions, excision of infected prosthetic mesh, redo incisional hernia repair with biologic mesh, bilateral component separations, debridement, drainage of massive recurrent abdominal wall seroma with sclerosis of the seroma cavity and anterior surface of cavity was excised.Relevant tests/laboratory data, including dates (b7) (b)(6)2014: pathology report from mesh specimen showed fibroadipose tissue with chronic inflammation and foreign body granulomatous inflammatory response.
|
|
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.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 acute ventral incisional hernia.It was reported that after implant, the patient experienced infection, adhesions, scarring, seroma, large clump of adipose tissue, chronic pain, fibroadipose tissue, inflammation, foreign body granulomatous inflammatory response and recurrence.P ost-operative patient treatment included revision surgery, exploration and reduction of recurrent incisional hernia, lysis of adhesions, excision of infected prosthetic mesh, redo incisional hernia repair with biologic mesh, bilateral component separations, debridement, drainage of massive recurrent abdominal wall seroma with sclerosis of the seroma cavity and anterior surface of cavity was excised.
|
|
Manufacturer Narrative
|
Additional information: a4, b2, b5, b7, g1, h4, h6 (ime, imf codes, h6 ime e2402: pink, irregular-looking masses on peritoneal surface biopsies).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 acute ventral i ncisional hernia.It was reported that after implant, the patient experienced infection, adhesions, scarring, seroma, large clump of adipose tissue, chronic pain, fibroadipose tissue, inflammation, foreign body granulomatous inflammatory response, recurrence, abscess, sepsis, stomach/bowel issues, pink, irregular-looking masses on peritoneal surface biopsies, sac contained large segment of colon.Post-operative patient treatment included revision surgery, exploration and reduction of recurrent incisional hernia, lysis of adhesions, biopsy, excision of infected prosthetic mesh, redo incisional hernia repair with biologic mesh, bilateral component separations, debridement, drainage of massive recurrent abdominal wall seroma with sclerosis of the seroma cavity, anterior surface of cavity was excised, medication.Relevant tests/laboratory data, including dates (b7) (b)(6) 2014: pathology report from mesh specimen showed fibroadipose tissue with chronic inflammation and foreign body granulomatous inflammatory response.
|
|
Search Alerts/Recalls
|
|
|