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

Model Number TECT1510AL

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

Patient Problems Adhesion(s) (1695); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Pain (1994); Hernia (2240); 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 laparoscopic therapeutic treatment of a hernia.It was reported that after implant, the patient experienced adhesions, pain, and foreign body giant cell reaction.Post-operative patient treatment included revision surgery.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for laparoscopic therapeutic treatment of a hernia.It was reported that after implant, the patient experienced adhesions, pain, foreign body giant cell reaction, recurrence, inflammation, allergic reaction, loss of domain.Post-operative patient treatment included revision surgery.

• 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 ; 60 middletown ave.; 8200 coral sea st ne; mounds view,mn, CT 55112 ; 7635265677
• MDR Report Key: 11462097
• MDR Text Key: 239106886
• Report Number: 9615742-2021-00537
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521180321
• UDI-Public: 10884521180321
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K982532
• 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: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Model Number: TECT1510AL
• Device Catalogue Number: TECT1510AL
• Device Lot Number: SOD1025X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/20/2024
• Date Device Manufactured: 05/08/2014
• 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
• Treatment: TECT1510AR ANAT RT STD PY 15X10CM (LOT#SOE0289X); TECT1510AR ANAT RT STD PY 15X10CM (LOT#SOE0289X)
• Patient Outcome(s): Required Intervention
• Patient Sex: Male
• Patient Weight: 120 KG