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

Model Number PNP6X3

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

Patient Problems Abdominal Pain (1685); Ecchymosis (1818); Hematoma (1884); Pain (1994); Burning Sensation (2146); Hernia (2240); Discomfort (2330); Numbness (2415); Unspecified Tissue Injury (4559)

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 left inguinal hernia.It was reported that after implant, the patient experienced recurrence, pain, abdominal pain, ecchymosis, hematoma, left inguinodynia, burning discomfort, numbness, and burning sensation after ejaculation.Post-operative patient treatment included removal of testicle, hernia repair, and medication.

• 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: 11548179
• MDR Text Key: 241706696
• Report Number: 9615742-2021-00629
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 20884521176420
• UDI-Public: 20884521176420
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101519
• 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: 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2016
• Device Model Number: PNP6X3
• Device Catalogue Number: PNP6X3
• Device Lot Number: SLH00527
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/03/2021
• Initial Date FDA Received: 03/22/2021
• Date Device Manufactured: 09/10/2011
• 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
• Patient Weight: 76