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

Device Problems Material Deformation (2976); Migration (4003)

Patient Problem Pain (1994)

Event Date 09/21/2012

Event Type  Injury  

Event Description

Progrip x 2 and same surgery perfix plug x1, bilateral inguinal and umbilical.Surgery was outpatient done by laparoscope.Since (b)(6) 2012 daily "profanity" on earth 24/7.All symptoms of: inguinodynia dysejaculation and reverse ejaculation, 100% of those issues.None of those issues ever prior to the surgery.A (b)(6) years old day of surgery and then i looked age 41, many said, and very healthy fit man.Now (b)(6), i look old from 6 1/2 years of daily agony.Pain, tightness, stabbing like a rope with blades tied around my inguinals, and my puffy buddha belly from the plug never stops hurting.The pain in the inguinals, on bad days, radiates down to my ankles up to my shoulders.Many radiology about the mesh entrapment of 3+ nerves an artery and my sperm cord; 70% less output of fluid upon ejaculation and size of erection is 40% less too.Too many issues to list them all.Since the surgery i have spent 200% of the total surgery cost on consults and more.Since surgery, no job, no income, no sex, no insurance.Now i don't have the (b)(6) with pre pay discount required to have the meshes all 3 removed by laparo, by a great surgeon.Unreal, your agency lets progrip and perfix plug still be implanted.Per my surgeon, he invented progrip.The meshes l/r moved and bunched up and gripping my artery and nerves and sperm cord.Dehumanizing and now my career skills rusty and hard to get a job, let alone at age (b)(6).Shame on covidien and bard.Medtronic and bard and shame on fda for ever approving those meshes.Done in (b)(6).I live in (b)(6), single, divorced a long time, want to still father children.I don't have the money, but in 2014, i tried a few times fibrenza, a herbal product that eats scar tissue but it's so $$$ i can't buy it now.Just still have the 3 hernia meshes implanted because i don't have the money to pay for the surgery to remove the meshes, with a great surgeon and facility.

• Brand Name: PROGRIP
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 8270885
• MDR Text Key: 134087249
• Report Number: MW5083298
• Device Sequence Number: 2
• 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: 01/18/2019
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Disability
• Patient Age: 64 YR
• Patient Weight: 61