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

Model Number PCO2015

Device Problems Migration or Expulsion of Device (1395); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Hernia (2240); 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 an abdominal hernia.It was reported that after implant, the patient experienced mesh contraction, balled up, wadded up, mesh floating free, recurrence, and abdominal pain.

• Brand Name: MESH SOFRADIM - PARIETEX COMPOSITE MESH
• 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 02048 ; 2034925563
• MDR Report Key: 10995730
• MDR Text Key: 221225782
• Report Number: 9615742-2020-02833
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040998
• 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: 12/11/2020

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: 11/01/2013
• Device Model Number: PCO2015
• Device Catalogue Number: PCO2015
• Device Lot Number: PIK00694
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/18/2020
• Initial Date FDA Received: 12/12/2020
• 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): Other