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); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Erosion (1750); Purulent Discharge (1812); Fistula (1862); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Staphylococcus Aureus (2058); Swelling (2091); Discharge (2225); Hernia (2240); Injury (2348); Impaired Healing (2378); Bowel Perforation (2668); Fluid Discharge (2686); Foreign Body In Patient (2687); No Code Available (3191); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)

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 pain, migration and recurrence.Post-operative patient treatment included revision and removal surgery.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a recurrent abdominal incisional hernia.It was reported that after implant, the patient experienced pain, migration, recurrence, infection, intermittent drainage, abscess, hole in colon repaired with suture, swelling, drainage of pus, redness, inflammation, colocutaneous fistula, adhesions, mesh erosion into viscera, open wound, and a portion of the stratus was just floating and was removed.Post-operative patient treatment included revision surgery, wound vac, abdominal wound exploration, and removal surgery.

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: a2(date of birth), a4(weight in lbs.) a5b(change to black or african american) b5, b6, b7, d1, d4(model#, catalog#, expiration date, lot#), d7, g4, g5, h6 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.

Manufacturer Narrative

Additional information: a4, b5, b7, e1(facility name, street 1, city, region, postal code), g1(manufacturer name, first name, last name, street 1, city, region, postal code, email, phone), h6(patient codes), additional code 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 recurrent abdominal incisional hernia.It was reported that after implant, the patient experienced bacterial infection, pain, migration, recurrence, infection, intermittent drainage, abscess, hole in colon repaired with suture, swelling, drainage of pus, redness, inflammation, colocutaneous fistula, adhesions, mesh erosion into viscera, open wound, and a portion of the stratus was just floating and was removed.Post-operative patient treatment included revision surgery, wound vac, abdominal wound exploration, ct-scan, hernia repair with mesh, and removal surgery.Relevant tests/laboratory data: 01/16/2012: wound/sinus culture was + for 2+ e coli, 1+ gram negative bacilli.Determined to be klebsiella pneumoniae.(b)(6) 2012: abdominal wound abscess culture with 3+ wbcs, mrsa+.(b)(6) 2012: pathology report from mesh specimen showed foreign material consistent with synthetic mesh.(b)(6) 2012: ct of abdomen/pelvis for recent hernia mesh infection and drainage from abdominal midline incision showed no localized fluid collection seen in operative bed.(b)(6) 2012: ct of the abdomen showed large ventral wound, high density material extending from colon into the wound, suspicious for colon-cutaneous fistula.(b)(6) 2012: pathology report from excised colocutaneous fistula showed 10 cm segment of colon entirely encase in adipose tissue.Mucosa slightly edematous.

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.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a recurrent abdominal incisional hernia.It was reported that after implant, the patient experienced bacterial infection, pain, migration, recurrence, infection, intermittent drainage, abscess, hole in colon repaired with suture, swelling, drainage of pus, redness, inflammation, colocutaneous fistula, adhesions, mesh erosion into viscera, open wound, mrsa, and a portion of the stratus was just floating and was removed.Post-operative patient treatment included revision surgery, wound vac, abdominal wound exploration, ct-scan, hernia repair with mesh, and removal surgery.Relevant tests/laboratory data: on (b)(6) 2012: wound/sinus culture was + for 2+ e coli, 1+ gram negative bacilli.Determined to be klebsiella pneumoniae.On (b)(6) 2012: abdominal wound abscess culture with 3+ wbcs, mrsa+.On (b)(6) 2012: pathology report from mesh specimen showed foreign material consistent with synthetic mesh.(b)(6) 2012: ct of abdomen/pelvis for recent hernia mesh infection and drainage from abdominal midline incision showed no localized fluid collection seen in operative bed.On (b)(6) 2012: ct of the abdomen showed large ventral wound, high density material extending from colon into the wound, suspicious for colon-cutaneous fistula.On (b)(6) 2012: pathology report from excised colocutaneous fistula showed 10 cm segment of colon entirely encase in adipose tissue.Mucosa slightly edematous.

• 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 ; 60 middletown ave.; 8200 coral sea st ne; mounds view,mn, CT 55112 ; 7635265677
• MDR Report Key: 8768061
• MDR Text Key: 150283251
• Report Number: 9615742-2019-02456
• 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
• Report Date: 01/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2014
• Device Model Number: PCO2015
• Device Catalogue Number: PCO2015
• Device Lot Number: PJJ000456
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/18/2023
• 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): Required Intervention
• Patient Sex: Female
• Patient Weight: 113 KG
• Patient Race: Black Or African American