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

Model Number PCO2520X

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); Fistula (1862); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Nerve Damage (1979); Pain (1994); Perforation (2001); Seroma (2069); Discharge (2225); Hernia (2240); Discomfort (2330); Injury (2348); Impaired Healing (2378); Obstruction/Occlusion (2422); Fluid Discharge (2686); No Code Available (3191); Unspecified Tissue Injury (4559)

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 implant, the patient experienced soreness, abdominal pain, chronically draining wound, recurrence, mesh erosion into small bowel, multiple fistula tracts, abscess, and dense adhesions of mesh to small bowel. Post-operative patient treatment included revision surgery, mesh removal, and small bowel resection.

• 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: justin ellis ; 5920 longbow drive; 8200 coral sea st ne; mounds view,mn, CT 55112 ; 7635265677
• MDR Report Key: 10748689
• Report Number: 9615742-2020-02418
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521179837
• UDI-Public: 10884521179837
• 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
• Report Date: 07/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 10/30/2013
• Device Model Number: PCO2520X
• Device Catalogue Number: PCO2520X
• Device Lot Number: PLJ00371
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/12/2023
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 11/03/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sex: Female
• Patient Weight: 95 KG
• Patient Treatment(s): UNKNOWN ABSORBATACK (LOT # UNKNOWN)
• Patient Outcome(s): Required Intervention