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

Model Number PCO2520

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

Patient Problems Ossification (1428); Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Purulent Discharge (1812); Fever (1858); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Scarring (2061); Vomiting (2144); Hernia (2240); Injury (2348); Impaired Healing (2378); Respiratory Failure (2484); Ascites (2596); Bowel Perforation (2668); 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 hernia. It was reported that after implant, the patient experienced perforated ileocolonic bowel anastomosis with abscess formation, sudden onset of retching, abdominal pain, bowel thickening/inflammation, puss under areas of mesh, infection, non-healing wound, fever, ventral hernia, incisional hernia, heterotopic ossification, dilated bowel, and abscess formation in the hepatorenal space on the right side. Post-operative treatment included repair of hole in small bowel, vac dressing, intubation within icu for 2 weeks, bilateral pleural effusions with atelectasis, repair of abdominal ventral hernia with mesh, debridement/washout of abdominal wound with removal of infected pieces of mesh, recurrent incisional hernia repair, and mesh resection.

• Brand Name: MESH SOFRADIM - PARIETEX¿ 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: 8497112
• MDR Text Key: 141381418
• Report Number: 9615742-2019-01137
• 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
• Report Date: 10/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: PCO2520
• Device Catalogue Number: PCO2520
• 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: 05/15/2019
• 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: 04/09/2019 Patient Sequence Number: 1