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

Model Number PCO15

Device Problems Loss of or Failure to Bond (1068); Migration or Expulsion of Device (1395); Material Perforation (2205); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Corneal Pannus (1447); Adhesion(s) (1695); Pain (1994); Hernia (2240); Injury (2348); Bowel Perforation (2668); No Code Available (3191); Unspecified Tissue Injury (4559)

Event Type  Injury  

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 laparoscopic therapeutic treatment of an incisional hernia. It was reported that after implant, the patient experienced recurrence, mesh partially unincorporated, adhesions, bowel perforation, and abdominal panniculus. Post-operative patient treatment included repair of recurrent incisional hernia with new ethicon prolene mesh, bilateral transverse abdominus myofascial flap advancement, removal of prior mesh, and panniculectomy.

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 laparoscopic therapeutic treatment of an incisional hernia. It was reported that after implant, the patient experienced recurrence and adhesions. Post-operative patient treatment included repair of recurrent incisional hernia with new ethicon prolene mesh, bilateral transverus abdominus myofascial flap advancement and removal of prior mesh.

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 laparoscopic repair incisional with mesh. He had revision surgery 6 months post surgery. The patient underwent laparoscopic repair recurrent incisional hernia. The patient experienced multiple surgical revisions, recurrent incisional hernia, mesh separation, abdominal wall 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: lisa hernandez ; 60 middletown ave; north haven, CT 06473 ; 2034925563
• MDR Report Key: 7027850
• MDR Text Key: 254320812
• Report Number: 9615742-2017-05706
• 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: 11/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 01/31/2013
• Device Model Number: PCO15
• Device Catalogue Number: PCO15
• Device Lot Number: PIB00432
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/10/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 11/14/2017 Patient Sequence Number: 1