MAUDE Adverse Event Report: BARD DAVOL 3DMAX HERNIA MESH

Device Problem Folded (2630)

Patient Problems Pain (1994); Ambulation Difficulties (2544); Foreign Body In Patient (2687)

Event Date 10/19/2017

Event Type  Injury  

Event Description

I have really bad pains in the left inguinal region where i had prior surgery for an inguinal hernia.Seen surgeon who ordered cat scan.Found out that hernia mesh was folded.Had surgery to remove it but a piece was left on the inguinal ligament.I have ilioinguinal and iliohypogastric neuroglia.I have been prescribed a walking cane to help me walk.I am in pain 24/7 and the pain is worse in the evening hours.I am still going through the diagnosis stages, so i may discover more damage.

• Brand Name: 3DMAX HERNIA MESH
• Type of Device: 3DMAX HERNIA MESH
• Manufacturer (Section D): BARD DAVOL
• MDR Report Key: 7227905
• MDR Text Key: 98708468
• Report Number: MW5074955
• 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: 01/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• 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): Hospitalization; Other; Disability
• Patient Age: 55 YR
• Patient Weight: 73