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

Model Number PCO4VP

Device Problems Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Emotional Changes (1831); Failure of Implant (1924); Unspecified Infection (1930); Pain (1994); Scar Tissue (2060); Hernia (2240); Distress (2329); Obstruction/Occlusion (2422); 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 incisional hernia. It was reported that after implant, the patient experienced damages, injuries, failure of mesh, pain, suffering, emotional distress, diminished quality of life, abdominal pain, infection, adhesions, bowel obstruction, defective design, disability, mental anguish, loss in capacity to enjoy life, scar tissue, recurrence, and impairment. Post-operative patient treatment included hospitalizations, prolonged antibiotic therapy, surgeries, wound care, narcotics, partial removal of mesh, debridement of fatty tissue muscle and fascia, and irrigation.

• 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: 12217522
• Report Number: 9615742-2021-01796
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521165700
• UDI-Public: 10884521165700
• 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
• Report Date: 07/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: PCO4VP
• Device Catalogue Number: PCO4VP
• Device Lot Number: PRJ8439X
• 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: 07/07/2021
• 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 Outcome(s): Hospitalization; Required Intervention; Disability