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

Model Number VTX5050M

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Material Split, Cut or Torn (4008)

Patient Problems Hernia (2240); Unspecified Tissue Injury (4559)

Event Date 03/06/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

According to reporter when the patient fell off an exam table at another doctors office they felt a pop, resulting in recurrence. The recurrence was later fixed robotically. The issue was post op, resulting in another repair of the recurrence. The original surgical procedure was an open repair of ventral incisional hernia and abdominal wall reconstruction and cholecystectomy. The size of the defect was 21m x 30cm. The location of the hernia is midline. The fixation system used was suture. The mesh was cut prior to implantation. The appearance of the mesh was normal. The patent outcome is alive - no injury.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Medtronic complaint number: (b)(4). If information is provided in the future, a supplemental report will be issued.

Event Description

Per additional information received the defect was repaired robotically, tear in mesh was closed with prolene suture. The mesh was not removed. No mesh was used due to gallbladder removal at same time.

• Brand Name: VERSATEX
• 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, CT 80301 ; 3035816943
• MDR Report Key: 6649870
• Report Number: 9615742-2017-05163
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521532298
• UDI-Public: 10884521532298
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150091
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility

Reporter Occupation

• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 10/31/2020
• Device Model Number: VTX5050M
• Device Catalogue Number: VTX5050M
• Device Lot Number: SPJ1016X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/08/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 11/19/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 125 KG
• Patient Outcome(s): Required Intervention