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

Model Number PCO2015X

Device Problems Product Quality Problem (1506); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Purulent Discharge (1812); Erythema (1840); Hematoma (1884); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Hernia (2240); Injury (2348); Impaired Healing (2378); Ascites (2596); Fluid Discharge (2686); No Code Available (3191); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

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 incisional hernia. It was reported that after implant, the patient experienced infected mesh, sinus tract (infection), omental adhesions, bowel adhesions and discoloration of mesh. Post-operative patient treatment included revision surgery.

Event Description

The patient¿s attorney alleged a deficiency against the device. The product was used for laparoscopic therapeutic treatment of an incisional hernia. It was reported that after implant, the patient experienced infected mesh, sinus tract (infection), draining wound infection, omental adhesions, bowel adhesions, abscess, abdominal pain, erythema, hematoma, collection of fluid, inflammation, recurrence, pain and discoloration of mesh. Post-operative patient treatment included revision surgery, incision/drainage of stitch abscess, debridement of abdominal wound with packing, incision/drainage of infected epigastric hematoma, debridement of abscess cavity and pulse lavage irrigation, excision of infected mesh, excision of the sinus tract skin and primary repair of incisional hernia.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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: 8145080
• MDR Text Key: 129746847
• Report Number: 9615742-2018-02714
• 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,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 07/31/2019
• Device Model Number: PCO2015X
• Device Catalogue Number: PCO2015X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/23/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 08/02/2014
• 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: 12/09/2018 Patient Sequence Number: 1

Treatment

PCO1510X PARIETEX PCOX 15X10 CM X1(LOT#POG0737X)