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

Model Number PCO2520

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

Patient Problems Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Erosion (1750); Foreign Body Reaction (1868); Granuloma (1876); Unspecified Infection (1930); Inflammation (1932); Nausea (1970); Pain (1994); Scar Tissue (2060); Seroma (2069); Hernia (2240); Discomfort (2330); Obstruction/Occlusion (2422); Ascites (2596); Fibrosis (3167); Nodule (4551); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical product: 174006 protack 5mm disp in (lot# p9b0382), abstack20 5mm sgl use abs dev 20 tacks (lot# unknown). (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. It was reported that after the implant, the patient experienced seroma, adhesions, recurrence, masses, keloid, abscess, mesh erosion, lipomas, scarring, ascites, abdominal masses, suture granulomas, fibrosis, patchy chronic inflammation, foreign body giant cell reaction, hemosiderin-laden macrophages, swelling, tenderness, ptosis of abdomen/mons pubis, loose mesh, fluid collection, diastasis, fascial laxity, nausea, and abdominal pain. Post-operative patient treatment included removal of mesh, evacuation of seroma, debridement of tissue/mesh, excision of lipomas, hernia repair with sutures, abdominoplasty, panniculectomy, mons pubis resection and pexy, lysis of adhesions, excision of small bowel mass/omental mass, and 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: tracy landers ; 5920 longbow drive; boulder,co, CT 80301 ; 3035816943
• MDR Report Key: 11821588
• MDR Text Key: 250627277
• Report Number: 9615742-2021-01097
• 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: 02/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 01/31/2014
• Device Model Number: PCO2520
• Device Catalogue Number: PCO2520
• Device Lot Number: PJB00126
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/02/2022
• 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: 05/13/2021 Patient Sequence Number: 1