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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN PROGRIP MESH MESH, SURGICAL, POLYMERIC

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COVIDIEN PROGRIP MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erosion (1750); Bruise/Contusion (1754); Inflammation (1932); Itching Sensation (1943); Pain (1994); Scar Tissue (2060); Burning Sensation (2146); Abdominal Distention (2601); Swelling/ Edema (4577)
Event Date 01/09/2019
Event Type  Injury  
Event Description
I had bilateral inguinal mesh implanted. It has caused severe bloating upon standing, severe pain, itching, burning, impotence, etc. The maker is covidien, progrip mesh. Pain and bloating since surgery. After two years, i suffered what was believed to be another injury where flesh pulled away from the mesh. I haven't been able to go back to work since the re-injury. I complained about pain for the last three years and finally got surgery on (b)(6) 2021. I was told this mesh cannot be removed and doctors believe i have nerve and vein impingement. The surgery consisted of bilateral spermatic cord denervation and varicelectomies. Unfortunately, the doctor could not fulfill his planned procedures because he found major spermatic cord inflammation and scar tissue. I am still recovering and waiting to see if it will produce pain relief. Four days out of surgery, i have lots of inflammation and serious pain while standing or walking. The dominate pain is below the incision on both sides of the base of the penis. I also have black and blue bruising on the right testicle and around the penis. A couple months after the mesh was implanted, i asked the surgeon to do exploratory surgery to see what was going on and i felt the mesh never attached properly. He refused and opted for pain management. Since surgery, i have had two nerve blocks which were not successful. I have been prescribed many different nerve pain/epileptic medications which are not helping with the pain that radiates at the testicle, inguinal and throughout the groin to the left and right hop. My surgeon is not sure why i have scar tissue and inflammation on the right cord but not the left cord. Since mesh implant surgery, most of the pain has been on the right side. I have been begging doctors to remove the mesh because i believe my body is rejecting it due to the pain and major abdominal swelling. If this surgery didn't work, they have a couple more options to try. My name is (b)(6). Thank you. Fda safety report id # (b)(4).
 
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Brand NamePROGRIP MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
COVIDIEN
MDR Report Key13025770
MDR Text Key282697654
Report NumberMW5106129
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 12/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was Device Evaluated by Manufacturer? No Answer Provided
Type of Device Usage

Patient Treatment Data
Date Received: 12/16/2021 Patient Sequence Number: 1
Treatment
ATENOLOL; IBUPROFEN; LEVOTHYROXINE; PREGABALIN; TYLENOL
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