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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: 3D MAX PROLINE MESH

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3D MAX PROLINE MESH Back to Search Results
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Pain (1994); Swelling (2091); Urinary Retention (2119)
Event Date 08/24/2009
Event Type  Injury  
Event Description

My name is (b)(6). In 2009, i had bilateral hernia repair surgery. Right after the surgery i experienced a lot of testicular pain and testicular swelling. The urologist told me there was some problem with the mesh. It had to be removed. I went back to the surgeon and he denied that, he was nothing to do with that so i saw another surgeon. They removed the mesh in the left side but still i'm unable to pass urine, unable to have sex. The last surgery was in (b)(6) 2011. They put a suprapubic catheter. They told me that they found the mesh in the midline right on top of the bladder. I want to complain to the first surgeon the way did he refused to fix my problem. When there was a time, i have a lawyer to do a medical malpractice and after one year my lawyer told me he's not going to continue with the case so he put me out. I don't understand why because before the inguinal hernia repair i just had a light pain in my pelvis. The ct showed a small hernia it was not even painful. So now i can't urinate i can't even have sex, completely disabled and i can't even have a lawsuit. Please, i'm so desperate. I am just looking for an answer. It's clear that i have a mesh migration. He did make a mistake. I was just fine before the surgery. Please let me know what to do. Thanks. Have a nice day.

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MDR Report Key2437957
MDR Text Key2514045
Report NumberMW5024080
Device Sequence Number1
Product Code FTL
Combination Product (Y/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 01/27/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/27/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Is this a Reprocessed and Reused Single-Use Device? No

Date Received: 01/27/2012 Patient Sequence Number: 1