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

Model Number SYM12

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Tissue Damage (2104)

Event Date 09/04/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the reporter: during a laparoscopic ventral hernia repair, the surgeon tried placing the mesh and when deploying tack, the mesh ripped and there were multiple holes in the mesh wherever a tack was placed.The surgeon had to remove the mesh.Replaced by new devices to complete the case.There were additional holes in the abdominal wall from using 2nd piece of mesh and tacker.The surgery was extended for more than 30 minutes.

• 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: 7911144
• MDR Text Key: 121779763
• Report Number: 9615742-2018-02180
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521190344
• UDI-Public: 10884521190344
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131969
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: SYM12
• Device Catalogue Number: SYM12
• Device Lot Number: PRL0963X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/04/2018
• Date Device Manufactured: 01/25/2018
• 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): Required Intervention
• Patient Age: 44 YR
• Patient Weight: 80