MAUDE Adverse Event Report: APOGEE MESH

Device Problem Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Bacterial Infection (1735); Erosion (1750); Pain (1994)

Event Date 11/22/2010

Event Type  Injury  

Event Description

I had a colporrhaphy combined a-p and enterocele repair and mid urethral sling operations.The apogee mesh was used.I developed infections as well as erosion due to the mesh, which resulted in another surgery for partial removal of the mesh.I have had continued pain, bacterial infections and am now having symptoms of pain in the intestinal region.

• Brand Name: APOGEE MESH
• Type of Device: APOGEE MESH
• MDR Report Key: 4235673
• MDR Text Key: 336227266
• Report Number: MW5038979
• Device Sequence Number: 1
• Product Code: OTP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 11/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/03/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR