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

Model Number SYM15F

Device Problems Degraded (1153); Product Quality Problem (1506)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/10/2017

Event Type  malfunction  

Event Description

According to the reporter, during a laparoscopic parastomal hernia repair procedure, while the mesh was being attached to the hernia defect, the device¿s mesh was damaged, wherein collagen film peeled off in the middle of the mesh in one area and the collagen was flaking around the outside.Saline was used to hydrate the mesh.Another piece of mesh was opened and used in order to resolve the issue.A 10/12 trocar was used.No patient injury.

Manufacturer Narrative

The visual examination of the returned sample shows that the sample was returned in its original aluminum pouch.The sample was found contaminated by blood.The mesh diameter is around 10 cm and the blue marker is not placed in the middle of the mesh.The mesh was found torn from the left of the blue marker, until the bottom of the mesh.A blue yarn suture is found from the tear.A hole about 3 cm diameter was found in the left side of the marker.In one quarter of the mesh (under the blue marker until the tear), the collagen was found flaking on the edge and lacking in nearly all of this part.The investigation has concluded that excessive tension is highly suspected.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SYMBOTEX
• 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: 7112345
• MDR Text Key: 94809436
• Report Number: 9615742-2017-06030
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521190405
• UDI-Public: 10884521190405
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K131969
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: SYM15F
• Device Catalogue Number: SYM15F
• Device Lot Number: PRG0426X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/14/2017
• Initial Date FDA Received: 12/13/2017
• Supplement Dates Manufacturer Received: 02/21/2018
• Supplement Dates FDA Received: 03/20/2018
• Date Device Manufactured: 07/26/2017
• 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