MAUDE Adverse Event Report: COLOPLAST MESH

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem Internal Organ Perforation (1987)

Event Date 08/10/2015

Event Type  Injury  

Event Description

Transvaginal mesh implanted in 2010 perforated my vagina (confirmed), possibly my bladder (unconfirmed), and just recently, my rectum.Two doctors have confirmed the vaginal mesh protrusion.Recently, the mesh is protruding out of my rectum but i have not seen a doctor.I have conflicting advice from 3 doctors on how to proceed.

• Brand Name: MESH
• Type of Device: MESH
• Manufacturer (Section D): COLOPLAST
• MDR Report Key: 5018957
• MDR Text Key: 23665820
• Report Number: MW5055607
• Device Sequence Number: 1
• Product Code: OTO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Report Date: 08/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Weight: 68