MAUDE Adverse Event Report: COVIDIEN PARIETEX; MESH

Model Number TECR1510

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Unspecified Infection (1930); Pain (1994); Scar Tissue (2060); Discomfort (2330); Fluid Discharge (2686)

Event Date 05/16/2013

Event Type  Injury  

Event Description

On (b)(6) 2013 was the day my life changed forever.I underwent laparoscopic hernia procedure that was supposed to fix my inguinal hernia.When i awoke the surgeon informed me that he repaired both sides, right and left with mesh.Ever since i have been experiencing sharp pains and uncomfortable feelings in my pelvis, hip and groin area.My right side was so bad that i had not been able to lift my leg to get in the car.I wasn't able to bend ii the way down and tie my own shoe.I wasn't even able to lift my leg without the aid of my own hands pulling it up.Last year my symptoms worsened on my left side.I have pictures to show and prove what has been going on.My left side felt like a brillo pad was breaking up into pieces under the surface of my skin.I had about 4-5 large noticeable lumps under my skin and was so uncomfortable, i couldn't put on pants or underwear without being in pain.It was depressing.I was not able to have sex for months even before the bulge got bigger.And still to this present day.After another month or so the lumps turned into one big bulge extending from my hip to my groin area.After another month or so the bulge turned purple, red and black.I went to the emergency room in (b)(6) 2016 and they did a cat scan.They said they saw scar tissue.By then the bulge was leaking in 2 different areas.One in my hip area and the other in my groin area.They prescribed me antibiotics and pain medicine.About a month or so later i was seen by my primary care doctor who sent a referral over to a surgeon to have things looked at and possibly have the mesh removed.Once i had talked to the surgeon he said the best option for me was to have my medical records sent from the hospital where the initial procedure took place.(b)(6) medical center was where the initial laparoscopic procedure took place by surgeon (b)(6) 2013.He also warned me that the best option was to have an extraction and a laparoscopy done where i would have to wear a wound vac for a minimum of 4-6 months while the inside heals secondarily.I learned that the mfr of the mesh was (b)(4).I have my model number and dates of expiration of the mesh put in me as well from my medical documents.My surgery is scheduled for next month and i have been in excruciating pain for the past 6 months as well.No sex! my performance at work has slowed down noticeably.It's been depressing taking all this pain medication that doesn't seem to work.I don't know how effective tramadol has been to other people, but it hasn't been that good for me.I've heard there was some claims against (b)(4) and other manufacturers of mesh and so i began to do some homework.Sure enough (b)(4) made the list of defective mesh among others.I can't work with a wound vac on much less do every day activity like i used to.I can't play with my kids like i used to.I can't work like i used to.And i can barely tie my own shoes because of the infected mesh (b)(4) has in me.I have been experiencing problems since the mesh was put in me.Sharp pains in my hips and groin area.Unable to lift my leg without help.Unable to stand for periods at a time without sharp pains shooting down from my hip to my leg making my leg literally give out unless i sit down.The worse it's gotten is recently when i had to go to the emergency room because the bulge was so big and painful, not to mention just down right uncomfortable i wasn't even able to have sexual relations, which i was pretty good at.It's still draining out of two different areas to this day and i have to keep changing bandages at the very least twice a day because of the leakage.I have an upcoming surgery scheduled for (b)(6) 2017 where the surgeon tells me i have to wear a wound vac afterwards for at least 4-6 months! not looking forward to that at all.He also tells me that they will have to cut through my abdomen and this procedure will be worse than what i am already going through! i was hospitalized on (b)(6) 2013 for intestinal blockage due to the hernia mesh.I plan to go to schedule a meeting with two news stations next month before my surgery to let people know not to get this procedure done using this mfr (b)(4) and the complications that could arise should they choose to go through with any procedures that contain the name (b)(4)!.

• Brand Name: PARIETEX
• Type of Device: MESH
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 6364008
• MDR Text Key: 68819792
• Report Number: MW5068170
• Device Sequence Number: 1
• Product Code: KDD
• 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: 02/26/2017

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?: No
• Device Operator: No Information
• Device Expiration Date: 06/01/2017
• Device Model Number: TECR1510
• Device Lot Number: SMJ00794
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/26/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: RX MEDS: CURRENTLY TAKING TRAMADOL FOR PAIN.
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Disability
• Patient Age: 34 YR
• Patient Weight: 77