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

Model Number PCO9X

Device Problems Migration or Expulsion of Device (1395); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Seroma (2069); Hernia (2240); Injury (2348); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 laparoscopic therapeutic treatment of an incisional ventral hernia.It was reported that after the implant, the patient experienced recurrence, subcutaneous fluid-filled mass, adhesions, seroma, mesh bowed in the mibline, and mesh migration.Post-operative patient treatment included revision surgery, lysis of adhesions, hernia repair, and excision of seroma.

• 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: 10254512
• MDR Text Key: 198309413
• Report Number: 9615742-2020-01545
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521179875
• UDI-Public: 10884521179875
• 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: 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2014
• Device Model Number: PCO9X
• Device Catalogue Number: PCO9X
• Device Lot Number: PMA00478
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/17/2020
• 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
• Patient Weight: 70