MAUDE Adverse Event Report: ETHICON PARIETEX PROGRIP

Model Number 847061

Device Problems Break (1069); Entrapment of Device (1212); Difficult to Remove (1528); Device Operates Differently Than Expected (2913)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Fever (1858); Nausea (1970); Scar Tissue (2060); Vomiting (2144); Hernia (2240); Therapeutic Response, Decreased (2271); Physical Entrapment (2327); Discomfort (2330); Obstruction/Occlusion (2422); Constipation (3274)

Event Date 01/27/2014

Event Type  Injury  

Event Description

I had a swiss cheese hernia in 2010, the mesh used was permacol mesh.(b)(6) 2011 i noticed a small bulge develop.Surgeon dismissed it and said it's nothing to worry about.On (b)(6)2011 i fell at work.Within days the bulge was the size of a grapefruit and my stomach extended like i was 6 months pregnant.I had hernia repair on (b)(6) 2012, the mesh used was parietex progrip.After surgery i could feel the mesh on the top and bottom of my abdomen.Since the surgery my stomach was still extended and a bulge on my right side of my stomach.The surgeon didn't take out any mesh that had broke into pieces.Had another surgery through (b)(6) on (b)(6) 2012, mesh used was mesh composite/ethicon.The old mesh was never addressed.Since 2010 i have been in constant pain, unable to have a bowel movement, nausea, vomiting, unknown fevers, pain in my hips and back and sciatic nerve pain.I have seen numerous doctors and i went back to my surgeon and a ct scan showed that i had a bowel obstruction.I spoke with the surgeon and he was going to fix the bowel obstruction which was caused by a piece of the broken mesh wrapped around the lower bowel, removal of adhesions and the removal of the mesh.The day of the surgery the surgeon refused to take out the mesh or cancel the surgery.I still have the pain.I went to a plastic surgeon and was told that the mesh is entwined with scar tissue and my stomach is still extended.The plastic surgeon called a couple of surgeons to see if they could help me.She told me that i should go to (b)(6) hospital to see if they can help me.My mesh from my 2010 surgery was starting to come apart, the fall split it into pieces.No doctor will help me because of the complications of the mesh.I still have all the same symptoms and still have problems going to the bathroom.My next option is (b)(6).

• Brand Name: PARIETEX PROGRIP
• Type of Device: PARIETEX PROGRIP
• Manufacturer (Section D): ETHICON
• MDR Report Key: 3695637
• MDR Text Key: 4247005
• Report Number: MW5035129
• Device Sequence Number: 2
• Product Code: OTP
• 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: 03/14/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/13/2016
• Device Model Number: 847061
• Device Catalogue Number: TEM1509G
• Device Lot Number: SLH00387
• Other Device ID Number: COVIDIEN 15X9CM
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/19/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 58 YR
• Patient Weight: 67