MAUDE Adverse Event Report: GYNECARE TVT-0; MESH

Model Number 810081L

Device Problem Insufficient Information (3190)

Patient Problems Bacterial Infection (1735); Muscle Spasm(s) (1966); Pain (1994); Anxiety (2328); Complaint, Ill-Defined (2331); Depression (2361); Ambulation Difficulties (2544); Weight Changes (2607)

Event Type  Injury  

Event Description

Tvt-o sling implanted for sui in 2010.Numerous vaginal "bacterial" infections, mesh erosion, dyspareunia, 2 partial mesh removals and still need more mesh removed.Increased depression, anxiety, weight gain due to inactivity because of pain, unable to climb stairs, pelvic/hip/groin pain.Muscle spasms, bladder spasms.

• Brand Name: TVT-0
• Type of Device: MESH
• Manufacturer (Section D): GYNECARE
• MDR Report Key: 3901848
• MDR Text Key: 19768712
• Report Number: MW5036882
• Device Sequence Number: 1
• Product Code: OTN
• 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: 06/22/2014

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 810081L
• Device Lot Number: 3374632
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/23/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention; Disability
• Patient Age: 35 YR
• Patient Weight: 73