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

Model Number PCO1510OSX

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001); Material Split, Cut or Torn (4008)

Patient Problems Adhesion(s) (1695); Unspecified Infection (1930); Internal Organ Perforation (1987); Pain (1994); Hernia (2240); Injury (2348); 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 recurrence and pain.Treatment provided for these conditions include revision surgery.

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 the implant, the patient experienced recurrence, adhesions, and pain.Post-operative patient treatment included revision surgery, lysis of adhesions, and recurrence repair of hernia.

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.

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 an incisional hernia.It was reported that after the implant, the patient experienced recurrence, adhesions, pain, mesh rupture, and bowel protrusion.Post-operative patient treatment included revision surgery, lysis of adhesions, recurrence repair of hernia, and mesh removal.

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 the implant, the patient experienced recurrence, adhesions, and pain.Post-operative patient treatment included revision surgery, lysis of adhesions, and recurrence repair of hernia.

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 an incisional hernia.It was reported that after the implant, the patient experienced recurrence, adhesions, pain, mesh rupture, infection, and bowel protrusion.Post-operative patient treatment included revision surgery, lysis of adhesions, recurrence repair of hernia, small bowel resection, and mesh removal.

• Brand Name: PARIETEX
• 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: 8001417
• MDR Text Key: 124878296
• Report Number: 9615742-2018-02428
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521179691
• UDI-Public: 10884521179691
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110816
• 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: 04/06/2022

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: PCO1510OSX
• Device Catalogue Number: PCO1510OSX
• Device Lot Number: PPK0266X
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/03/2018
• Initial Date FDA Received: 10/24/2018
• Supplement Dates Manufacturer Received: 05/22/2019; 05/22/2019; 11/11/2020; 03/16/2022
• Supplement Dates FDA Received: 11/26/2019; 02/12/2020; 12/02/2020; 04/06/2022
• Date Device Manufactured: 11/21/2015
• 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
• Patient Age: 42 YR
• Patient Sex: Female