MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ OPTIMIZED COMPOSITE MESH MESH, SURGICAL, POLYMERIC

Model Number PCO6VP

Device Problems Migration or Expulsion of Device (1395); Material Perforation (2205); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Purulent Discharge (1812); Fever (1858); Fistula (1862); Foreign Body Reaction (1868); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Inflammation (1932); Nausea (1970); Necrosis (1971); Nerve Damage (1979); Internal Organ Perforation (1987); Sepsis (2067); Seroma (2069); Vomiting (2144); Hernia (2240); Injury (2348); Obstruction/Occlusion (2422); Ascites (2596); Blood Loss (2597); Fluid Discharge (2686); 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 a ventral incisional hernia. It was reported that after implant, the patient experienced recurrence, bowel perforation, bowel obstruction, infection, adhesions, sepsis, abdominal pain, nausea, vomiting, hemorrhagic free fluid, hypotension, murky serous fluid, necrotic tissue, low grade fever, purulent drainage and left upper quadrant seroma with purulent fluid. Post-operative patient treatment included revision surgery.

• Brand Name: MESH SOFRADIM - PARIETEX¿ OPTIMIZED COMPOSITE MESH
• 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: lisa hernandez ; 60 middletown ave; north haven, CT 06473 ; 2034925563
• MDR Report Key: 8685440
• MDR Text Key: 147562258
• Report Number: 9615742-2019-01949
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120506
• 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: 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 06/10/2021
• Device Model Number: PCO6VP
• Device Catalogue Number: PCO6VP
• Device Lot Number: PQC0367
• 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: 09/11/2019
• 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: 06/10/2019 Patient Sequence Number: 1