MAUDE Adverse Event Report: MESH

Device Problems Device Or Device Fragments Location Unknown (2590); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/18/2010

Event Type  Injury  

Event Description

Mesh implanted to repair an inguinal hernia.It failed and i had an open surgery in (b)(6) 2012, 4 hours and the surgeon was unable to locate and remove the mesh.

• Brand Name: MESH
• Type of Device: MESH
• MDR Report Key: 7289239
• MDR Text Key: 100835194
• Report Number: MW5075445
• 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: 02/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2018
• 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): Required Intervention; Disability
• Patient Weight: 100