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

Model Number TECR1510

Device Problems Migration or Expulsion of Device (1395); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Diarrhea (1811); Purulent Discharge (1812); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Muscle Weakness (1967); Nausea (1970); Pain (1994); Vomiting (2144); Hernia (2240); Discomfort (2330); Foreign Body In Patient (2687); Nodule (4551); 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 patients attorney alleged a deficiency against the device.The product was used for laparoscopic therapeutic treatment of a left inguinal hernia.It was reported that after implant, the patient experienced nausea, blood in stool, pain, infection, hypoattenuating zone, abscess, staphylococcus aureus, inflammation, polarizable foreign material, vomiting, diarrhea, mass, purulent material, free floating mesh, mesh contraction, and recurrence.Post-operative patient treatment included revision surgery, admission to hospital, medication, iv fluids, drainage of abscess, hernia repair, evacuation of purulent material, jp drain, and mesh removal.

• 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, CO 55112 ; 7635265677
• MDR Report Key: 11861155
• MDR Text Key: 251927893
• Report Number: 9615742-2021-01347
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521180284
• UDI-Public: 10884521180284
• 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: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2013
• Device Model Number: TECR1510
• Device Catalogue Number: TECR1510
• Device Lot Number: SIG00345
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/20/2024
• Date Device Manufactured: 07/19/2008
• 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: ABSTACK20 5MM SGL USE ABS DEV 20 TACKS (LOT#U8H94)
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 102 KG
• Patient Race: White