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

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).

• Brand Name: PROGRIP MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 13025770
• MDR Text Key: 282697654
• Report Number: MW5106129
• 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: 12/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/16/2021
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: ATENOLOL; IBUPROFEN; LEVOTHYROXINE; PREGABALIN; TYLENOL
• Patient Outcome(s): Disability; Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 97 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White