MAUDE Adverse Event Report: MESH

Device Problem Extrusion (2934)

Patient Problem Pain (1994)

Event Date 04/28/2017

Event Type  Injury  

Event Description

The mesh was coming out in the vaginal wall causing pain during intercourse.

• Brand Name: MESH
• Type of Device: MESH
• MDR Report Key: 6746510
• MDR Text Key: 81309142
• Report Number: MW5071265
• 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: Unknown
• Type of Report: Initial
• Report Date: 07/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2017
• 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): Other
• Patient Age: 49 YR
• Patient Weight: 54