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

Model Number	SYM15F
Medical Device Problem Codes	Degraded (1153); Product Quality Problem (1506)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/10/2017
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• MDR Report Key: 7112345
• Report Number: 9615742-2017-06030
• Device Sequence Number: 19206274
• Product Code: FTL
• UDI-Device Identifier: 10884521190405
• UDI-Public: 10884521190405
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K131969
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 11/14/2017
• Supplement Date Received by Manufacturer: 02/21/2018
• Initial Report FDA Received Date: 12/13/2017
• Supplement Report FDA Received Date: 03/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1