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

Model Number PCO12X

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

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Pain (1994); Unspecified Tissue Injury (4559)

Event Type  Injury  

Event Description

The patient¿s attorney alleged a deficiency against the device. The product was used for therapeutic treatment of a umbilical hernia. It was reported that after implant, the patient experienced adhesions, abdominal wall pain and pain. Post-operative patient treatment included revision surgery, colon resection, hemorrhoidectomy, laparoscopic sleeve gastrectomy upper endoscopy, left leg vein stripping, laparoscopic cholecystectomy and intraoperative cholangiogram, mesh removal, lysis of adhesions and permanent synthetic tacks removal.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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 80301 ; 3035816943
• MDR Report Key: 12975374
• MDR Text Key: 282039185
• Report Number: 9615742-2021-02477
• 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: Consumer

Reporter Occupation

• Type of Report: Initial
• Report Date: 12/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 01/31/2015
• Device Model Number: PCO12X
• Device Catalogue Number: PCO12X
• Device Lot Number: PNB0297
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/23/2021
• 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: 12/10/2021 Patient Sequence Number: 1