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

Model Number PCO2015

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

Patient Problems Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Hematoma (1884); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Pain (1994); Skin Discoloration (2074); Discharge (2225); Hernia (2240); Injury (2348); Obstruction/Occlusion (2422); Blood Loss (2597); Abdominal Distention (2601); Fluid Discharge (2686); Unspecified Tissue Injury (4559)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical devices: gore dualmesh 26x34xl (product id: idlmc0, lot# 05512176); protack 5mm single use instrument (lot# p8d0642); unknown protack (lot# p8e0149). 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 infected mesh, adhesions, bowel obstruction, bloating, abdominal pain, hypotensive, pale, hemorrhage, hematoma, bleeding, sinus drainage, and abscess between the two layers of mesh. Post-operative patient treatment included revision surgery, admission to hospital, nasogastric intubation, lysis of adhesions, icu, antibiotics, repair with new mesh, and excision of infected mesh.

• 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: tracy landers ; 5920 longbow drive; boulder,co, CT 80301 ; 3035816943
• MDR Report Key: 10637769
• MDR Text Key: 210083685
• Report Number: 9615742-2020-02284
• 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

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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 02/28/2013
• Device Model Number: PCO2015
• Device Catalogue Number: PCO2015
• Device Lot Number: PIC00372
• 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: 10/06/2020 Patient Sequence Number: 1

Treatment

PROTACK 5MM SINGLE USE INSTRUMENT (LOT#P8C0689)