MAUDE Adverse Event Report: MEDTRONIC/COVIDIEN PARIETEX MESH AND PLUG

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Swelling (2091); Discomfort (2330); Abdominal Distention (2601)

Event Date 01/08/2015

Event Type  Injury  

Event Description

I had a surgical procedure for bilateral inguinal hernia repair.Prior to having the surgery, i never had pain, discomfort or severe swelling.After having the mesh and plugs inserted, i've been in constant pain, swelling of the vaginal area and bloating of the abdomen.I kept reporting it to the surgeon who stated that my symptoms were because of fluid build up and all symptoms would subside in a few weeks.That comment was made two years ago and i'm still in excruciating pain.I have medtronic parietex mesh and plugs.

• Brand Name: PARIETEX MESH AND PLUG
• Type of Device: PARIETEX MESH AND PLUG
• Manufacturer (Section D): MEDTRONIC/COVIDIEN
• MDR Report Key: 6386881
• MDR Text Key: 69512125
• Report Number: MW5068329
• 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: 03/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 59 YR
• Patient Weight: 58