MAUDE Adverse Event Report: COVIDIEN COVIDIEN PARIETEX PROGRIP MESH; MESH, SURGICAL, POLYMERIC

Device Problem Insufficient Information (3190)

Patient Problems Fainting (1847); Muscle Spasm(s) (1966); Pain (1994); Swelling (2091); Vomiting (2144); Chills (2191); Sweating (2444); Ambulation Difficulties (2544); Abdominal Distention (2601); Constipation (3274)

Event Date 12/18/2018

Event Type  Injury  

Event Description

I had right femoral hernia repair on (b)(6) 2018 at (b)(6) in (b)(6), surgeon used progrip mesh.I had pain, swelling, constipation, pelvic spasms, inability to walk, sit, work, could not wipe myself, incomplete bowel movements, bloating, swelling, vomiting, fainting, chills and night sweats.Deep ache pain with shooting pain into my labia and into my right inner thigh.Pain was not controlled by pain medications.I was on bed rest until i had the mesh removed on (b)(6) 2019 at same hosp by original surgeon.

• Brand Name: COVIDIEN PARIETEX PROGRIP MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 8473943
• MDR Text Key: 140809636
• Report Number: MW5085506
• 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: 03/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 47 YR
• Patient Weight: 58