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

Model Number PCO3728X

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

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Calcium Deposits/Calcification (1758); Foreign Body Reaction (1868); Granuloma (1876); Inflammation (1932); Necrosis (1971); Nerve Damage (1979); Pain (1994); Scar Tissue (2060); Hernia (2240); Injury (2348); Foreign Body In Patient (2687); Fibrosis (3167); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(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 mesh had rolled slightly and was impinging on nerves, pain, recurrence, fibroconnective soft tissue, degenerative changes, necrosis, meshoma, fibrous tissue, dystrophic calcifications, histiocytic, foreign body giant cell response, palpable nodule, neuroma/ neuralgia, adhesions, abdominal pain, foreign body material, scar tissue, granuloma, diastasis, inflammation, and nerve damage. Post-operative patient treatment included revision surgery, surgical procedure involving peritoneum, removal of mesh/ sutures, debridement, neurectomy, excision of left inguinal nerves, hernia closed with sutures, excision of soft tissue, hernia repair with new mesh, lysis of adhesions, diagnostic laparoscopy, biopsy of foreign material, excision of foreign body abdominal wall, removal of granuloma, panniculectomy, and meshoma removed.

• Brand Name: PARIETEX
• 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: 10445781
• MDR Text Key: 204166182
• Report Number: 9615742-2020-01892
• 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
• Report Date: 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 03/31/2015
• Device Model Number: PCO3728X
• Device Catalogue Number: PCO3728X
• Device Lot Number: PND0311
• 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: 08/05/2020
• 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: 08/24/2020 Patient Sequence Number: 1