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

Model Number PCO2520

Device Problems Product Quality Problem (1506); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Erosion (1750); Diarrhea (1811); Purulent Discharge (1812); Unspecified Infection (1930); Pain (1994); Sepsis (2067); Discharge (2225); Hernia (2240); Discomfort (2330); Injury (2348); Depression (2361); Impaired Healing (2378); Bowel Perforation (2668); Fluid Discharge (2686); No Code Available (3191); Unspecified Tissue Injury (4559)

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 resulting in an unspecified adverse outcome.Product was used for therapeutic treatment.The patient underwent a repair of recurrent abdominal wall incisional hernia with mesh.He had revision surgery 2 years and 1 month post-surgery.The patient underwent exploratory laparotomy with lysis of adhesions.The patient experienced adhesions.

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.(b)(4).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 abdominal incisional hernia.It was reported that after the implant, the patient experienced mesh erosion into viscera, recurrence, adhesions, infection, several areas of draining in the midline, abdominal pain, sepsis, mesh with foul odor and greenish discoloration, hole in colon leaking succus, and open wound.Post-operative patient treatment included revision surgery, exploratory laparotomy, removal of infected mesh, partial colectomy, complex closure of abdominal wall, bilateral component separation, placement of wound vac, and lysis of adhesions.

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.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of an abdominal incisional hernia.It was reported that after the implant, the patient experienced mesh erosion into viscera, recurrence, adhesions, infection, several areas of draining in the midline, and open wound.Post-operative patient treatment included revision surgery, exploratory laparotomy, removal of infected mesh, partial colectomy, placement of wound vac, and lysis of adhesions.

Manufacturer Narrative

Additional information: a4, b2, b5, b7, d8, e1, g1, h4, h6 (ime, imf, device 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 an abdominal incisional hernia.It was reported that after the implant, the patient experienced mesh erosion into viscera, recurrence, adhesions, infection, several areas of draining in the midline, abdominal pain, sepsis, mesh with foul odor and greenish discoloration, hole in colon leaking succus, open wound, pain, diarrhea, depression, tenderness in stomach.Post-operative patient treatment included revision surgery, exploratory laparotomy, removal of infected mesh, partial colectomy, complex closure of abdominal wall, bilateral component separation, placement of wound vac, lysis of adhesions, hernia repair with new mesh, medication.

• 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: 7084222
• MDR Text Key: 93766503
• Report Number: 9615742-2017-05889
• 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: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/14/2024

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: 06/30/2015
• Device Model Number: PCO2520
• Device Catalogue Number: PCO2520
• Device Lot Number: PKG00319
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/13/2017
• Initial Date FDA Received: 12/05/2017
• Supplement Dates Manufacturer Received: 06/05/2019; 06/05/2019; 07/31/2024
• Supplement Dates FDA Received: 12/12/2019; 01/09/2020; 08/14/2024
• Date Device Manufactured: 07/25/2010
• 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): Required Intervention; Other; Life Threatening
• Patient Age: 44 YR
• Patient Sex: Male
• Patient Weight: 91 KG