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

Model Number PCO3020

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Bacterial Infection (1735); Unspecified Infection (1930); Pain (1994); Staphylococcus Aureus (2058); Hernia (2240); Injury (2348); Impaired Healing (2378); 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 adhesions, infection, and recurrence. Treatment provided for these conditions include mesh removal.

Event Description

The patient¿s attorney alleged a deficiency against the device. The product was used for therapeutic treatment of an incisional hernia. It was reported that after underlay implant, the patient experienced adhesions, infection, open wound, mrsa, chronic pain, exposed mesh and recurrence. Post-operative patient treatment included revision surgery, mesh removal, rives-stoppa repair with release of posterior sheath and transversus abdominis musculature, two bilateral muscle advancements, myofascial advancement of rectus muscle to midline for closure of hernia and placement of retrorectus mesh, finally debridement of skin and primary closure and lysis of adhesions.

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 an inguinal hernia. It was reported that after implant, the patient experienced adhesions, infection, open wound, and recurrence. Post-operative patient treatment included revision surgery, mesh removal, and lysis of adhesions.

Event Description

The patient¿s attorney alleged a deficiency against the device. The product was used for therapeutic treatment of an incisional hernia. It was reported that after underlay implant, the patient experienced adhesions, infection, open wound, mrsa, and recurrence. Post-operative patient treatment included revision surgery, mesh removal, rives-stoppa repair with release of posterior sheath and transversus abdominis musculature, two bilateral muscle advancements, myofascial advancement of rectus muscle to midline for closure of hernia and placement of retrorectus mesh, finally debridement of skin and primary closure 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.

• 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: 8167818
• MDR Text Key: 130462073
• Report Number: 9615742-2018-02774
• 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: 01/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 07/31/2015
• Device Model Number: PCO3020
• Device Catalogue Number: PCO3020
• Device Lot Number: PKH00274
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/15/2021
• 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: 12/16/2018 Patient Sequence Number: 1