MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ COMPOSITE MESH; MESH, SURGICAL, POLYMERIC

Model Number PCO2015

Device Problems Migration or Expulsion of Device (1395); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Abdominal Pain (1685); Abscess (1690); Anemia (1706); Bacterial Infection (1735); Purulent Discharge (1812); Emotional Changes (1831); Erythema (1840); Fistula (1862); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Staphylococcus Aureus (2058); Scar Tissue (2060); Scarring (2061); Discharge (2225); Injury (2348); Impaired Healing (2378); Ascites (2596); Fluid Discharge (2686); No Code Available (3191); 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 hernia.It was reported that after implant, the patient experienced chronic pain, infected mesh, and severe scarring.Post-operative patient treatment included removal surgery.

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 incisional hernia.It was reported that after implant, the patient experienced infected mesh, open wound, abscess, fistula, fluid collection, small locules of gas, inflammation, sinus tracts, (b)(6), purulent discharge, abdominal pain, indurated wound, wound dehiscence, erythema, erythematous with copious discharge, anemia, phlegmon, mesh folded, pus surrounding mesh, mental pain, pain, disability, impairment, loss of enjoyment of life, defective mesh, and severe scarring.Post-operative patient treatment included removal surgery, incision and drainage of abscess, patient hospitalized, antibiotics, procrit and iron infusions, wound vac, excision of anterior abdominal wall fistulous tracts, excision of large abdominal wall phlegmon, and wound care.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of an incisional hernia.It was reported that after implant, the patient experienced chronic pain, infected mesh, open wound, abscess, fistula, fluid collection, small locules of gas, inflammation, sinus tracts, (b)(6), purulent discharge, abdominal pain, indurated wound, wound dehiscence, erythema, erythematous with copious discharge, anemia, phlegmon, mesh folded, pus surrounding mesh, and severe scarring.Post-operative patient treatment included removal surgery, incision and drainage of abscess, patient hospitalized, antibiotics, procrit and iron infusions, wound vac, excision of anterior abdominal wall fistulous tracts, excision of large abdominal wall phlegmon, and wound care.

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.If information is provided in the future, a supplemental report will be issued.

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: (weight in lbs), description of event or problem, other relevant history, 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 incisional hernia.It was reported that after implant, the patient experienced chronic pain, infected mesh, open wound, abscess, fistula, and severe scarring.Post-operative patient treatment included removal surgery.

Manufacturer Narrative

Additional information: b5, e1 (facility name, street 1, city, region, postal code), h4, device codes), additional 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.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of an incisional hernia.It was reported that after implant, the patient experienced infected mesh, open wound, abscess, fistula, fluid collection, small locules of gas, inflammation, sinus tracts, staphylococcus aureus mrsa, purulent discharge, abdominal pain, indurated wound, wound dehiscence, erythema, erythematous with copious discharge, anemia, phlegmon, mesh folded, pus surrounding mesh, mental pain, pain, disability, impairment, loss of enjoyment of life, defective mesh, and severe scarring.Post-operative patient treatment included removal surgery, incision and drainage of abscess, patient hospitalized, antibiotics, procrit and iron infusions, wound vac, excision of anterior abdominal wall fistulous tracts, excision of large abdominal wall phlegmon, ct scan, hernia repair with new mesh, and wound care.Relevant tests/laboratory data: on (b)(6) 2012: history physical: ct abdomen/pelvis- anterior abdominal wall wound and fluid collection anterior to the peritoneal cavity and deep to the abdominal wall musculature.Small locules of gas noted.On (b)(6) 2012: ed documentation: ct scan of abdomen showed continued chronic inflammatory changes in the anterior abdomen with gas present, fistulas suspected.On (b)(6) 2012: mri abdomen: anterior abdominal wall inflammation with sinus tracts and fistula communicating with skin.Multiple defects noted.On (b)(6) 2012, wound culture with very light staphylococcus aureus mrsa.

Manufacturer Narrative

Additional information: a5a (patient ethnicity) 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.

• Brand Name: MESH SOFRADIM - PARIETEX¿ COMPOSITE MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• Manufacturer (Section G): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• Manufacturer Contact: justin ellis ; 5920 longbow drive; 8200 coral sea st ne; mounds view,mn, CT 55112 ; 7635265677
• MDR Report Key: 8167810
• MDR Text Key: 130460878
• Report Number: 9615742-2018-02769
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2015
• Device Model Number: PCO2015
• Device Catalogue Number: PCO2015
• Device Lot Number: PKB00345
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/05/2018
• Initial Date FDA Received: 12/16/2018
• Supplement Dates Manufacturer Received: 06/05/2019; 06/05/2019; 01/26/2022; 08/30/2023; 10/11/2023
• Supplement Dates FDA Received: 12/23/2019; 02/28/2020; 02/10/2022; 09/04/2023; 10/17/2023
• Date Device Manufactured: 02/27/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Sex: Female
• Patient Weight: 104 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American