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U.S. Department of Health and Human Services

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

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JOHNSON AND JOHNSON/ETHICON TVT BLADDER SLING Back to Search Results
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.

 
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Brand NameTVT BLADDER SLING
Type of DeviceBLADDER SLING
Manufacturer (Section D)
JOHNSON AND JOHNSON/ETHICON
MDR Report Key6116247
MDR Text Key60635933
Report NumberMW5066187
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
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 Received11/17/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 11/17/2016 Patient Sequence Number: 1
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