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

Model Number PCO12

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Diarrhea (1811); Fever (1858); Nausea (1970); Pain (1994); Swelling (2091); Hernia (2240); Discomfort (2330); Injury (2348); Abdominal Distention (2601); No Code Available (3191); Constipation (3274)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: pco12 parietex comp 3d py 12 cir nothr (lot# ple00299). (b)(4). 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 laparoscopic therapeutic treatment of an incisional hernia at the umbilicus. It was reported that after the implant, the patient experienced recurrence, adhesions, acute constipation, diarrhea, discomfort, chronic pain, fever, swelling, nausea, distention, abdominal pain, ibs, gallstones, cholelithiasis, symptomatic/chronic cholecystitis, and suffering. Post-operative patient treatment included revision surgery, lysis of adhesions, cholecystectomy, esophagogastroduodenoscopy (egd) with biopsies gej and gastric antrum/body, and hernia repair with new 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: 10071308
• MDR Text Key: 191449871
• Report Number: 9615742-2020-01147
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040998
• 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: 06/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: PCO12
• Device Catalogue Number: PCO12
• Device Lot Number: PKH00480
• 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: 06/10/2020
• 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: 05/19/2020 Patient Sequence Number: 1