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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHYO. MESH HERNIA MESH

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PHYO. MESH HERNIA MESH Back to Search Results
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.

 
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Brand NamePHYO. MESH
Type of DeviceHERNIA MESH
MDR Report Key7472666
MDR Text Key107064593
Report NumberMW5076892
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
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 Received04/27/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 04/27/2018 Patient Sequence Number: 1
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