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

Model Number TEM1208GR

Device Problems Loss of or Failure to Bond (1068); Migration or Expulsion of Device (1395); 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); Hemorrhage/Bleeding (1888); Laceration(s) (1946); Internal Organ Perforation (1987); Pain (1994); Discharge (2225); Hernia (2240); Injury (2348); Ascites (2596); Blood Loss (2597); Fluid Discharge (2686); 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 laparoscopic therapeutic treatment of a ventral hernia. It was reported that after implant, the patient experienced recurrence, extensive adhesions, serosal tears, abscess in left lateral abdominal area, leakage, mesh that pulled away from fascial edges, and bleeding. Post-operative patient treatment included exploratory laparotomy, recurrent incisional hernia repair with new bard mesh, omentum and small bowel attached to the inferior aspect of the mesh were dissected, all segment of composite mesh extended to below the umbilicus at the midline was excised, placement of bard mesh, bowel was teased off of the mesh and the abdominal wall, repair of serosal tears, removal of previous mesh, placement of new covidien permacol mesh, drainage of intrabdominal abscess as well as three areas of small bowel required resection: part that had leaked, torn during lysis of adhesions, and was devascularized from tearing and having bleeding.

• Brand Name: PROGRIP
• 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: 8518541
• MDR Text Key: 142074906
• Report Number: 9615742-2019-01318
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081050
• 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,Followup,Followup
• Report Date: 01/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 06/30/2013
• Device Model Number: TEM1208GR
• Device Catalogue Number: TEM1208GR
• Device Lot Number: SIG00200
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/12/2022
• 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: 04/16/2019 Patient Sequence Number: 1

Treatment

PCO2015, TEM1208GL