MAUDE Adverse Event Report: ETHICON GYNECARE TENSION-FREE VAGINAL TAPE SYSTEM; MESH, SURGICAL, SYNTHETIC

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Erosion (1750); Foreign Body Sensation in Eye (1869)

Event Date 04/05/2017

Event Type  Injury  

Event Description

Had a gynecare trans-vaginal tape obturator put in (b)(6) 2011 for stress urinary incontinence.Then in (b)(6) 2016 started feeling pressure and like something was stuck inside my vagina.Had doctor check and said all was ok.Then in (b)(6) 2017, i went back into doctor due to continued pressure and feeling like something was still stuck.Doctor then referred me to a specialist who in (b)(6) 2017 confirmed that the mesh had eroded into the vaginal wall.On (b)(6) 2017 i had to have the mesh surgical removed.

• Brand Name: GYNECARE TENSION-FREE VAGINAL TAPE SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC
• Manufacturer (Section D): ETHICON
• MDR Report Key: 6830574
• MDR Text Key: 84068666
• Report Number: MW5071842
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• 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: 08/28/2017

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: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/30/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Weight: 71