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

Model Number PCO2520

Device Problems Migration or Expulsion of Device (1395); Material Perforation (2205); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Foreign Body Reaction (1868); Failure of Implant (1924); Internal Organ Perforation (1987); Pain (1994); Excessive Tear Production (2235); Hernia (2240); Injury (2348); Obstruction/Occlusion (2422); Fibrosis (3167); 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.The product was used for therapeutic treatment of a hernia.It was reported that after implant, the patient experienced recurrent hernia due to failure of the mesh, dense adhesions, bowel entrapment, tearing of the small intestine and pain.Treatment provided for these conditions include removal surgery.

Manufacturer Narrative

(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 laparoscopic therapeutic treatment of an incisional hernia.It was reported that after implant, the patient experienced recurrent hernia due to failure of the mesh, serosal tearing, dense adhesions, bowel entrapment, tearing of the small intestine and pain.Post-operative patient treatment included lysis of adhesions, bilaterally myofascial rectus advancement flaps, bilaterally myofascial transverse muscle advancement flap, revision surgery and removal of 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.The product was used for laparoscopic therapeutic treatment of an incisional hernia.It was reported that after implant, the patient experienced recurrent hernia due to failure of the mesh, serosal tearing, dense adhesions, bowel entrapment, tearing of the small intestine and pain.Post-operative patient treatment included lysis of adhesions, bilaterally myofascial rectus advancement flaps, bilaterally myofascial transverse muscle advancement flap, revision surgery and removal of mesh.The device has been used with unknown protacks.

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 recurrent hernia due to failure of the mesh, serosal tearing, dense adhesions, bowel entrapment/obstruction, tearing of the small intestine, mesh migration, fibrosis, foreign body giant cell reaction, and pain.Post-operative patient treatment included lysis of adhesions, bilaterally myofascial rectus advancement flaps, bilaterally myofascial transverse muscle advancement flap, revision surgery, and removal of mesh.

Manufacturer Narrative

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: tracy landers ; 5920 longbow drive; boulder,co, CT 80301 ; 3035816943
• MDR Report Key: 7972499
• MDR Text Key: 123934382
• Report Number: 9615742-2018-02315
• 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,Followup
• Report Date: 01/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2014
• Device Model Number: PCO2520
• Device Catalogue Number: PCO2520
• Device Lot Number: PKA00399
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/15/2021
• 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
• Treatment: UNK PROTACK (LOT# UNKNOWN)
• Patient Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Weight: 90 KG