MAUDE Adverse Event Report: PHYO. MESH; HERNIA MESH

Device Problems Difficult to Remove (1528); Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Perforation (2001); Hernia (2240); Ambulation Difficulties (2544)

Event Date 04/22/2014

Event Type  Injury  

Event Description

I had mesh for a pelvic hernia that had re-herniated after prior hernia surgery.Then in 2016 i had surgery again same pelvic area, same hernia.The mesh was attached to my bladder and colon.The surgeon tried to pick the mesh off my bladder, pierced my bladder had to stop and could not remove the mesh.He put more mesh close to my pelvic bone.I still have mesh on my bladder and colon.I have seen several doctors, some told me it needed removal, all of the doctors are afraid to mess with this problem, but all of them tell me how bad it will be if it gets worse.I am having very bad pain, it hurts me to walk very much.I contacted a lawyer and they said i needed more medical information.I don't know where to go with this, but i need some help.I have had 4 surgeries for this problem and i still have a hernia and mesh and colon problems.Surgeries - 2014 - 2016.

• Brand Name: PHYO. MESH
• Type of Device: HERNIA MESH
• MDR Report Key: 7472666
• MDR Text Key: 107064593
• Report Number: MW5076892
• 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: 04/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 69 YR
• Patient Weight: 75