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

Model Number PCO6VP

Device Problems Loss of or Failure to Bond (1068); Migration or Expulsion of Device (1395); Material Perforation (2205); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Adhesion(s) (1695); Pain (1994); Swelling (2091); Hernia (2240); Injury (2348); No Code Available (3191); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)

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 severe pain, swelling, omental adhesions, recurrence, eventration of the mesh, mesh pulled away from the repair, lack of incorporation, and partial mesh excision.

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 severe pain, swelling, omental adhesions, recurrence, eventration of mesh, mesh pulled away from the repair and lack of incorporation.Post-operative patient treatment included partial mesh excision.

Manufacturer Narrative

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 a hernia.It was reported that after the implant, the patient experienced inflammation, nerve damage, severe pain, swelling, omental adhesions, recurrence, eventration of mesh, mesh pulled away from the repair and lack of incorporation.Post-operative patient treatment included partial mesh excision, mesh removal, medication, hernia repair with mesh.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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: 8093079
• MDR Text Key: 128014919
• Report Number: 9615742-2018-02607
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521514157
• UDI-Public: 10884521514157
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142908
• 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
• Report Date: 02/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: PCO6VP
• Device Catalogue Number: PCO6VP
• Device Lot Number: PQC0891X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/18/2022
• Date Device Manufactured: 04/08/2016
• 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 Sex: Female
• Patient Weight: 93 KG