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

Lot Number PRK1515X

Device Problem Migration or Expulsion of Device (1395)

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

Event Date 03/26/2019

Event Type  malfunction  

Event Description

Tissue came through the mesh.Mesh was removed and replaced.

• Brand Name: SYMBOTEX
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION; covidien; 60 middletown ave; north haven CT 06473
• MDR Report Key: 8472706
• MDR Text Key: 140592979
• Report Number: 8472706
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: PRK1515X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/29/2019
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 04/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 13505 DA