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

Model Number PCO4VP

Device Problems Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Adhesion(s) (1695); Erosion (1750); Unspecified Infection (1930); Pain (1994); Staphylococcus Aureus (2058); Discharge (2225); Injury (2348); Impaired Healing (2378); Blood Loss (2597)

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 an incisional hernia.It was reported that after implant, the patient experienced adhesions, pain, bleeding, erosion, and infections.Treatment provided for these conditions include excision surgery, lysis of adhesions and vac.

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 implant, the patient experienced adhesions, pain, bleeding, erosion, open wound and infections.Post-operative patient treatment include revision surgery, excision of mesh, lysis of adhesions and wound vac.

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

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 incisional hernia.It was reported that after implant, the patient experienced adhesions, pain, bleeding, erosion, open wound, draining wound, (b)(6), and infections.Post-operative patient treatment include revision surgery, excision of mesh, lysis of adhesions and wound vac.

• Brand Name: MESH SOFRADIM - PARIETEX¿ OPTIMIZED COMPOSITE MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• MDR Report Key: 8011824
• MDR Text Key: 125270359
• Report Number: 9615742-2018-02480
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521165700
• UDI-Public: 10884521165700
• Combination Product (y/n): N
• PMA/PMN Number: K120506
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/18/2019

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: 03/31/2020
• Device Model Number: PCO4VP
• Device Catalogue Number: PCO4VP
• Device Lot Number: PPC1099X
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/03/2018
• Initial Date FDA Received: 10/28/2018
• Supplement Dates Manufacturer Received: 05/22/2019; 05/22/2019
• Supplement Dates FDA Received: 12/11/2019; 12/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR