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

Model Number TEM1515G

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

Patient Problems Abscess (1690); Adhesion(s) (1695); Purulent Discharge (1812); Hematoma (1884); Unspecified Infection (1930); Scar Tissue (2060); Sepsis (2067); Obstruction/Occlusion (2422); Lethargy (2560); Ascites (2596); Fibrosis (3167); 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 a ventral hernia. It was reported that after implant, the patient experienced infection, small bowel obstruction, sepsis, hematoma, adhesions, murky fluid in cavity, fluid collection, fibrous capsule, sepsis, lethargy, serosal tear, scarring, and abscess. Post-operative patient treatment included removal of mesh, placement of new mesh, small bowel resection with stapled anastamosis, placement of wound vac, drainage of murky fluid, admission to hospital, lysis of adhesions, patient in critical condition, picc line placed, and incision/drainage of abscess.

• 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: lisa hernandez ; 60 middletown ave.; north haven, CT 06473 ; 2034925563
• MDR Report Key: 11572361
• MDR Text Key: 242375829
• Report Number: 9615742-2021-00661
• 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

• Type of Report: Initial,Followup
• Report Date: 04/09/2021

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 03/25/2021
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device EXPIRATION Date: 11/30/2014
• Device MODEL Number: TEM1515G
• Device Catalogue Number: TEM1515G
• Device LOT Number: SJL00332
• Was Device Available For Evaluation?: No

Is The Reporter A Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/24/2021
• 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: 03/25/2021 Patient Sequence Number: 1