MAUDE Adverse Event Report: BARD DAVOL IND. / C.R. BARD, INC. BARD PER FIX PLUG; MESH, SURGICAL, POLYMERIC

Device Problem Nonstandard Device (1420)

Patient Problems Pain (1994); Unspecified Reproductive System or Breast Problem (4513)

Event Date 08/10/2015

Event Type  Injury  

Event Description

I had inguinal hernia surgery to repair the hernia's.From day one zi had pain but the surgeon told me to man up.Over a period of years contacting 3 other surgeons, they all said to go to back the doctor who performed the original surgery.I told all 3 of them that the original surgeon refused to help me.After the 5 years i finally found 2 doctors to help me.On both sides the bard per fix plug mesh had wrapped so tightly around the spermatic cord causing extreme pain that when they tried to remove the mesh from the cords, they could not due to risk of damaging cord.The doctors did 4 more surgeries to remove both left and right cords and testicles.They also had to remove all 3 nerves on both sides.So i have to ask you, how come you the fda did not do your own testing of this mesh instead of giving them a pass without your testing? there is another 60 to 70 thousand of patients that are and have suffered due to the mesh that you refused to test.I must tell you to drop the bard per fix plug and all polypropylene mesh.There are thousands of patients who feel you are protecting, the mesh companies are making billions of money while we live with pain for many years.After i lost both of my testicles because of the bard mesh i am on, testosterone therapy for the rest of my life.Put in me on (b)(6) 2015 ( when it was recalled).Fda safety report id# (b)(4).

• Brand Name: BARD PER FIX PLUG
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): BARD DAVOL IND. / C.R. BARD, INC.
• MDR Report Key: 14376313
• MDR Text Key: 291644616
• Report Number: MW5109657
• 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: 05/10/2022

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/11/2022
• Patient Sequence Number: 1
• Treatment: ATORVASTATIN; BLOOD PRESSURE MEDICINE
• Patient Outcome(s): Disability; Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Race: White