MAUDE Adverse Event Report: JOHNSON AND JOHNSON/ETHICON TVT BLADDER SLING

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Urinary Retention (2119); Abnormal Vaginal Discharge (2123)

Event Date 11/09/2015

Event Type  Injury  

Event Description

Reporter said that she is having complications from the sling that was implanted for urinary incontinence.Reporter stated that her legs are hurting when she walks.She also said she is having severe vaginal pain, vaginal discharge, and difficulty urinating.She said she wanted the implant removed but has not found a doctor as of yet.

• Brand Name: TVT BLADDER SLING
• Type of Device: BLADDER SLING
• Manufacturer (Section D): JOHNSON AND JOHNSON/ETHICON
• MDR Report Key: 6116247
• MDR Text Key: 60635933
• Report Number: MW5066187
• Device Sequence Number: 1
• Product Code: FTL
• 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: 11/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR
• Patient Weight: 71