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

Model Number PCO6VP

Device Problems Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Purulent Discharge (1812); Emotional Changes (1831); Erythema (1840); Unspecified Infection (1930); Pain (1994); Scar Tissue (2060); Hernia (2240); Discomfort (2330); Injury (2348); Obstruction/Occlusion (2422); No Code Available (3191); Unspecified Tissue Injury (4559)

Event Type  Injury  

Manufacturer Narrative

(b)(4). 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 and umbilical hernia. It was reported that after implant, the patient experienced infection/ infected mesh, adhesions of bowel to mesh, abdominal pain, erythema, induration, tenderness, abscess, purulent material, and pain. Post-operative patient treatment included revision surgery, removal of mesh, small bowel resection with primary anastamosis, closure of abdominal wall, and incision/drainage of abscess.

• 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: 10518445
• MDR Text Key: 206485480
• Report Number: 9615742-2020-01995
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142908
• 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
• Report Date: 02/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 03/31/2021
• Device Model Number: PCO6VP
• Device Catalogue Number: PCO6VP
• Device Lot Number: PQD0670X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 04/21/2016
• 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: 09/10/2020 Patient Sequence Number: 1