MAUDE Adverse Event Report: HERNIA MESH; MESH, SURGICAL, POLYMERIC

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Burning Sensation (2146)

Event Date 08/07/2009

Event Type  Injury  

Event Description

I got a inguinal hernia repair around (b)(6) 2016 but i'm always in pain, burning and throbbing.How can i find out what kind of mesh i have? i was told i don't have a hernia but probably my body is rejecting the mesh.Fda safety report id# (b)(4).

• Brand Name: HERNIA MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• MDR Report Key: 8866467
• MDR Text Key: 153696481
• Report Number: MW5088843
• 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: 08/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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): Disability
• Patient Age: 51 YR
• Patient Weight: 69