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 Device Interaction Problem (4001)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Purulent Discharge (1812); Emotional Changes (1831); Erythema (1840); Inflammation (1932); Muscle Weakness (1967); Nausea (1970); Necrosis (1971); Pain (1994); Perforation (2001); Scar Tissue (2060); Vomiting (2144); Hernia (2240); Discomfort (2330); Obstruction/Occlusion (2422); Ascites (2596); Abdominal Distention (2601); Fluid Discharge (2686); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); 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 umbilical hernia. It was reported that after implant, the patient experienced adhesions, recurrence, dilated fluid-filled small bowel loops, free air, ascites, attenuation, inflammation, diastases, tenderness, abdominal pain, pain, ileus, erythema, distention, turbid fluid, enterotomy, frozen abdomen, serosal tear, perforation, edematous, vomiting of green fluid, nausea, necrosis, purulent material, and small bowel obstruction. Post-operative patient treatment included revision surgery, mesh removal, steroid injections, admission to hospital, medication, antibiotics, small bowel resection, wound vac, serosal tears repaired, perforation site closed, tpn, and lysis of adhesions.

• 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: 12285380
• MDR Text Key: 265354508
• Report Number: 9615742-2021-01899
• 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,Followup
• Report Date: 04/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 02/28/2016
• Device Model Number: PCO6VP
• Device Catalogue Number: PCO6VP
• Device Lot Number: PNC0035
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/16/2022
• 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: 08/05/2021 Patient Sequence Number: 1