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

Model Number PCO2520X

Device Problems Material Erosion (1214); Material Perforation (2205); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Abscess (1690); Adhesion(s) (1695); Erosion (1750); Fistula (1862); Unspecified Infection (1930); Internal Organ Perforation (1987); Perforation (2001); Hernia (2240); Injury (2348); Bowel Perforation (2668); No Code Available (3191); 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. Product was used for therapeutic treatment of an incisional hernia. It was reported that after implant, the patient experienced adhesions, recurrence, mesh erosions into viscera, bowel perforation, infection, abscess, and fistula. Post-operative patient treatment included revision surgery, mesh removal, hernia repair with mesh and lysis of adhesions.

Event Description

The patient's attorney alleged a deficiency against the device resulting in an unspecified adverse outcome. Product was used for therapeutic treatment. The patient underwent a hernia repair with mesh. He had revision surgery 6 months post-surgery. The patient experienced additional surgery, adhesions, bowel perforation, fistula, and mesh removal.

• Brand Name: UNKNOWN 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: 7175777
• MDR Text Key: 282737186
• Report Number: 9615742-2018-00087
• Device Sequence Number: 1
• Product Code: FTL
• 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: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 06/30/2014
• Device Model Number: PCO2520X
• Device Catalogue Number: PCO2520X
• Device Lot Number: PMF00649
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/01/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 01/09/2018 Patient Sequence Number: 1