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

Model Number DXT1612AR

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/07/2022

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during a laparoscopic bilateral inguinal hernia repair procedure, while implanting the mesh, the mesh did not align properly with the anatomy of the patient because of the anatomical properties of the mesh. This caused the inferior portion of the mesh to not lay properly. The surgeon also stated that the mesh did not give enough medical coverage for the surgeon to feel comfortable leaving the mesh in place. The surgeon decided to use a different mesh to complete the case and resolve the issue. There was no patient injury.

• Brand Name: DEXTILE
• 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: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 14215606
• MDR Text Key: 290148646
• Report Number: 9615742-2022-00371
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 07/21/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: DXT1612AR
• Device Catalogue Number: DXT1612AR
• Device Lot Number: SVF0517X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial