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

Model Number PCO2015

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

Patient Problems Corneal Pannus (1447); Adhesion(s) (1695); Fistula (1862); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Perforation (2001); Seroma (2069); Hernia (2240); Injury (2348); Weight Changes (2607); Fibrosis (3167); No Code Available (3191); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

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

According to the reporter: the patient had to have a panniculectomy because fat necrosis had grown onto the mesh and was hurting.The patient has been hospitalized and has had two hernia repairs since then.Both times, additional mesh was installed.The event report type is serious injury and the event outcome is hospitalization.

Manufacturer Narrative

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.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 dense adhesions and fistula.Post-operative patient treatment included small bowel resection.

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 a ventral incisional hernia.It was reported that after implant, the patient experienced dense adhesions, subserosal tissues associated with fibrosis, granulomatous foreign body reaction, weight loss, panniculus, and fistula.Post-operative patient treatment included small bowel re section, abdominal panniculectomy, lap and open ventral hernia repair, separation of components with mobilization of skin flaps with tissue rearrangement, small bowel resection, repair of colotomy, lap to open ventral hernia repair, placement of ventralight mesh, mobilization of skin flaps, tissue arrangement, complex wound closure, mesh explanation, mobilization of tissue flap, complex wound closure and lysis of adhesions relevant tests/laboratory data, including dates: (b)(6) 2014: pathology report- small bowel shows foreign material in subserosal tissues associated with fibrosis and granulomatous foreign body reaction probably representing mesh material.

Manufacturer Narrative

Additional info: a4, b5, b7, d8, e1 (facility name, street, city, region, postal code), h6 (updated all codes, added patient codes, imf codes, device code and ime e2402: "weight loss, panniculus").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 a ventral incisional hernia.It was reported that after implant, the patient experienced pain, infection, recurrence, inflammation, allergic reaction, obstruction, seroma, perforation, dense adhesions, subserosal tissues associated with fibrosis, granulomatous foreign body reaction, weight loss, panniculus, and fistula.Post-operative patient treatment included medication, small bowel resection, abdominal panniculectomy, lap and open ventral hernia repair, separation of components with mobilization of skin flaps with tissue rearrangement, small bowel resection, repair of colotomy, lap to open ventral hernia repair, placement of ventralight mesh, mobilization of skin flaps, tissue arrangement, complex wound closure, mesh explanation, mobilization of tissue flap, complex wound closure and lysis of adhesions.

• 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 avenue; 8200 coral sea st ne; mounds view,mn, CT 55112 ; 7635265677
• MDR Report Key: 6637296
• MDR Text Key: 77450882
• Report Number: 9615742-2017-05158
• 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,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/20/2024

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: 10/31/2015
• Device Model Number: PCO2015
• Device Catalogue Number: PCO2015
• Device Lot Number: PKJ08661
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/15/2017
• Initial Date FDA Received: 06/13/2017
• Supplement Dates Manufacturer Received: 05/15/2017; 05/15/2019; 05/15/2019; 08/14/2024
• Supplement Dates FDA Received: 10/04/2017; 08/15/2019; 09/29/2019; 08/21/2024
• 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
• Patient Sex: Female
• Patient Weight: 91 KG