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

Model Number PCO1510OS

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

Patient Problems Adhesion(s) (1695); Unspecified Infection (1930); Necrosis (1971); Pain (1994); Swelling (2091); Discharge (2225); Excessive Tear Production (2235); Hernia (2240); Injury (2348); Impaired Healing (2378); Obstruction/Occlusion (2422); 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 two incarcerated incisional hernias. It was reported that after implant, the patient experienced small bowel obstruction, bowel stuck between mesh and abdominal wall, succus underneath mesh, pinpoint size hole in the small bowel, necrotic tissue, recurrent incisional hernia, multiple adhesions, pain, defect inferior and right of mesh, infection, bowel adherence to mesh, superficial serosal tearing in bowel and periodic swelling. Post-operative treatment included wound vac placement, enterotomy, necrotic tissue removal from abdominal wound, recurrent incisional hernia repair with new mesh, removal of two previously placed pieces of covidien mesh due to infection, and drainage of enteric contents.

• 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: 8515513
• MDR Text Key: 141972888
• Report Number: 9615742-2019-01297
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050187
• 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
• Report Date: 10/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 11/01/2011
• Device Model Number: PCO1510OS
• Device Catalogue Number: PCO1510OS
• Device Lot Number: P3L00327
• 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: 04/15/2019 Patient Sequence Number: 1