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

Model Number PCO2H3

Device Problems Material Integrity Problem (2978); Mechanics Altered (2984); 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); Emotional Changes (1831); Fatigue (1849); Fistula (1862); Hemorrhage/Bleeding (1888); Failure of Implant (1924); Unspecified Infection (1930); Inflammation (1932); Nausea (1970); Nerve Damage (1979); Internal Organ Perforation (1987); Pain (1994); Scar Tissue (2060); Chills (2191); Hernia (2240); Discomfort (2330); Deformity/ Disfigurement (2360); Weight Changes (2607); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

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 a hiatal hernia.It was reported that after the implant, the patient experienced mental pain/anguish, physical pain, permanent injury, physical deformity, abdominal pain, nausea, chills, loss of appetite, weight loss, infection, scarring, adhesions, abscess, discomfort, failure of mesh, defective mesh, disfigurement, mesh erosion, mesh contraction, fistula, inflammation, scar tissue, organ perforation, recurrence, dyspareunia, blood loss, neuropathic, nerve damage, and lack of energy.Post-operative patient treatment included revision surgery, drainage of infection, pain medication, operations to attempt to repair organs/tissue/nerve damage, and removal of mesh.

• 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: 11118692
• MDR Text Key: 225141001
• Report Number: 9615742-2021-00024
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521178465
• UDI-Public: 10884521178465
• 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
• Report Date: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/30/2013
• Device Model Number: PCO2H3
• Device Catalogue Number: PCO2H3
• Device Lot Number: PJA00069
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/09/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention