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

Model Number PCO3020X

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

Patient Problems Adhesion(s) (1695); Ischemia (1942); Hernia (2240); Obstruction/Occlusion (2422); 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 ventral hernia.It was reported that after the underlay implant, the patient experienced closed loop obstruction from adhesion of the mesh to small bowel, adhesions, recurrence, and ischemia.Post-operative patient treatment included revision surgery, lysis of adhesions, component separation, closure of abdominal wall, reduction of hernias, and hernia repair with new mesh.

• 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: lisa hernandez ; 60 middletown ave; north haven, CT 06473 ; 2034925563
• MDR Report Key: 11116623
• MDR Text Key: 225057048
• Report Number: 9615742-2021-00018
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521179851
• UDI-Public: 10884521179851
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110815
• 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
• Report Date: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2021
• 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: PCO3020X
• Device Catalogue Number: PCO3020X
• Device Lot Number: PML00412
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/09/2020
• 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