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

Model Number PCO9X

Device Problems Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Abscess (1690); Adhesion(s) (1695); Erosion (1750); Purulent Discharge (1812); Fistula (1862); Foreign Body Reaction (1868); Granuloma (1876); Hematoma (1884); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Seroma (2069); Discharge (2225); Hernia (2240); Discomfort (2330); Injury (2348); Impaired Healing (2378); Fibrosis (3167); No Code Available (3191)

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 an incarcerated incisional hernia. It was reported that after implant, the patient experienced recurrence, draining sinus, subcutaneous abscess drainage with seropurulent material, adhesions, hematoma, draining serous material from incision, seroma, lateral hernia, mesh erosion, and granuloma. Post-operative patient treatment included excision of draining sinus, incision and drainage of wound abscess, mesh edges excised, incisional hernia recurrence requiring placement of new mesh, lysis of adhesions, aspiration of hematoma and seroma, excision of small bowel with mesh erosion, excision of old mesh, adhesions removed, partial excision of mesh, as well as excision of suture sinus and suture granuloma.

• 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, CT 80301 ; 3035816943
• MDR Report Key: 8783153
• MDR Text Key: 150809408
• Report Number: 9615742-2019-02519
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 12/31/2018
• Device Model Number: PCO9X
• Device Catalogue Number: PCO9X
• Device Lot Number: POA0508X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/03/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 01/27/2014
• 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: 07/11/2019 Patient Sequence Number: 1