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

Model Number UNKNOWN PARIETEX

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

Patient Problems Foreign Body Sensation in Eye (1869); Seroma (2069); Burning Sensation (2146)

Event Date 07/21/2017

Event Type  Injury  

Manufacturer Narrative

Title: prospective randomized controlled trial comparing partially absorbable lightweight mesh and multifilament polyester anatomical mesh in laparoscopic inguinal hernia repair source.Asian journal of endoscopic surgery.11 (2018) 146¿150.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, they compared the surgical handling and clinical outcomes between two different types of mesh used in a laparoscopic total extraperitoneal inguinal hernia repair.There were 85 eligible patients and 42 were implanted with the mesh, the remaining patients were implanted with a competitor mesh.A total of 38 patients that were implanted with the mesh results were reviewed, and it was reported that 9 patients experienced post-operative seroma.Foreign body sensation and chronic postoperative neuralgia or presence of intermittent hyperesthesia, burning sensation, and/or jabbing pain in the ipsilateral inguinal area was assessed at 12 months after the operation.

• Brand Name: UNKNOWN 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: 8177103
• MDR Text Key: 130763594
• Report Number: 9615742-2018-02852
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN PARIETEX
• Device Catalogue Number: UNKNOWN PARIETEX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2018
• 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): Other
• Patient Age: 58 YR