MAUDE Adverse Event Report: VAGINAL MESH

Device Problems Explanted (1217); Leak/Splash (1354); Malfunction (2409)

Patient Problem Pain (1994)

Event Date 08/04/2016

Event Type  Injury  

Event Description

Patient states she has had pain since the mesh was implanted in 2013. She still has some leakage and states she has pain with intercourse that is worsening.

• Brand Name: Unknown Brand Name
• Type of Device: VAGINAL MESH
• MDR Report Key: 5882759
• MDR Text Key: 52410515
• Report Number: 5882759
• Device Sequence Number: 1
• Product Code: FTL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/08/2016
• Distributor Facility Aware Date: 08/04/2016
• Device Age: 3 YR
• Event Location: Hospital

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient Treatment Data

Date Received: 08/16/2016 Patient Sequence Number: 1