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

Model Number PCO12X

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

Patient Problems Wound Dehiscence (1154); Abscess (1690); Adhesion(s) (1695); Purulent Discharge (1812); Erythema (1840); Fever (1858); Fistula (1862); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Internal Organ Perforation (1987); Perforation (2001); Pleural Effusion (2010); Sepsis (2067); Discharge (2225); Hernia (2240); Injury (2348); Impaired Healing (2378); Obstruction/Occlusion (2422); Ascites (2596); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: pco20, lot number: plb00291; pco12x , lot number: plh00283. 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 incarcerated incisional hernias. It was reported that after a procedure where this device was implanted, the patient experienced multiple surgical revisions, recurrent incarcerated incisional hernias requiring placement of new mesh for repair, dense adhesions (lysed over 2. 5 hours), enterotomy repair, effaced bowel, excision, infection, abdominal abscess, small bowel perforation, foul-smelling puss from abdominal wound, placement of wound vac because they were unable to close the abdominal wall d/t bowel perforation and open wound, primary repair of small bowel perforation and exchange of wound vac, abdominal wound sepsis, wound exploration, removal of wound vac, incision and drainage of right lateral abdominal wall, placement of new mesh to repair defect, small bowel obstruction. After treatment, the patient experienced 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: 8600610
• MDR Text Key: 144728427
• Report Number: 9615742-2019-01674
• 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,Followup
• Report Date: 01/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 09/30/2013
• Device Model Number: PCO12X
• Device Catalogue Number: PCO12X
• Device Lot Number: PLI00523
• 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: 12/27/2019
• 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: 05/10/2019 Patient Sequence Number: 1