MAUDE Adverse Event Report: VICYL; HERNIA MESH

Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590)

Patient Problems Pain (1994); Swelling (2091)

Event Date 05/27/2014

Event Type  Injury  

Event Description

First surgeon dr.(b)(6) did a radical prostate cancer surgery including surgery removing cancerous tissue outside and around prostate on (b)(6) 2014.Second surgery by dr.(b)(6) on (b)(6) 2014 using 2 mesh plugs to repair mesh name vicyl and monocryl.Third surgeon dr.(b)(6) on (b)(6) 2014 used vicyl and monocryl and polypropylene to repair hernia which had become even larger, he was also unable to locate one of the plugs first put in.Now the mesh is still not holding and the hernia has become even larger and more severe pain, swelling, and when we saw the last surgeon again he advised us against another surgery, the tissue is already so damaged from mesh.Another surgery would be dangerous and most likely would not hold.In other words there is nothing left to do to help me!.

• Brand Name: VICYL
• Type of Device: HERNIA MESH
• MDR Report Key: 6900207
• MDR Text Key: 87768870
• Report Number: MW5072520
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/27/2017
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 88