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

Model Number TET3030

Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Wound Dehiscence (1154); Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Erosion (1750); Purulent Discharge (1812); Foreign Body Reaction (1868); Unspecified Infection (1930); Inflammation (1932); Nausea (1970); Staphylococcus Aureus (2058); Scar Tissue (2060); Discharge (2225); Excessive Tear Production (2235); Hernia (2240); Injury (2348); Impaired Healing (2378); Obstruction/Occlusion (2422); Ascites (2596); Abdominal Distention (2601); Fibrosis (3167); 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 an incarcerated umbilical hernia. It was reported that after implant, the patient experienced recurrence, numerous adhesions, old mesh incorporated some of scar tissue, subacute fascial wound dehiscence with exposed viscera, right edge of mesh had pulled off of fascia and exposed bowel and mesentery at periumbilical wound, dense abdominal wall adhesions where the bowel had subacutely eviscerated, dense intraabdominal adhesions, serosal tears, mesh had odor and foul-smelling, bowel leak from a distal jejunal enterotomy with significant succus in abdomen, old incorporated mesh that was seeding the sinus tract, infection, ascites, abscess, and purulent discharge. Post-operative patient treatment included recurrent incarcerated incisional hernia repair with mesh, incarcerated omentum was reduced, excised bulk of the old mesh, removal of old infected mesh, incarcerated tissue was reduced, extensive lysis of adhesions required to free anterior abdominal wall and mobilize small bowel off surgical site and mesh, repair to serosal tears, segmental small bowel resection, debridement of anterior abdominal wall, excision of intraperitoneal and anterior abdominal wall mesh, vac dressing applied, abdominal washout, abdominal wall closure with mesh, abdominal re-exploration for postoperative sepsis, evacuated turbid fluid sitting in central lower abdomen, incision and drainage of right retroperitoneal abscess as well as thick, tan, purulent fluid was obtained and lastly, ventral/incisional hernia repair with mesh.

• 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: 8765211
• MDR Text Key: 150171588
• Report Number: 9615742-2019-02425
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K982532
• 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: 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 12/31/2012
• Device Model Number: TET3030
• Device Catalogue Number: TET3030
• Device Lot Number: SHL00395
• 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: 06/05/2019
• 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: 07/05/2019 Patient Sequence Number: 1