MAUDE Adverse Event Report: ETHICON, INC. GYNECARE TVT-O SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RET

Model Number 810081

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Incontinence (1928); Pain (1994); Urinary Frequency (2275)

Event Date 03/28/2018

Event Type  Injury  

Event Description

History of present illness: presents to hospital for follow-up for pelvic pain and voiding dysfunction, incontinence in the setting of prior sling.Urinary symptoms include: prior to sling, she had stress urinary incontinence (sui).Since the sling, she still has sui, but also bothersome urgency and urge associated incontinence.It sounds like the incontinence occurs equally with both.She reports daytime urinary frequency every 1-2 hours.Nocturia x3-4.No hesitancy.Some symptoms of incomplete emptying.She needs to positional void to empty.Stream is normal.Some dribbling.She is wearing pads.Previously, she has tried: nothing aside from the sling.No hematuria.No urinary tract infections.On exam, she had pain over the arms of her sling, but also had pain at her cuff, over her bladder, and was exquisitely tender over her levators bilaterally and her levators are spastic procedure: removal of tot midurethral sling, anterior repair, cystourethroscopy procedural findings: on eua, no pelvic masses.Notably patient also recently had normal pelvic ultrasound.No vaginal mesh erosion.The sling was quite deep and proximal near the bladder neck.The vaginal portion was removed on either side to the level of the pubic rami, about 4cm total length.On cystoscopy at the end of the procedure, there was no bladder or urethral injury, no mesh in the bladder, and she had strong bilateral ureteral efflux.

• Brand Name: GYNECARE TVT-O SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RET
• Manufacturer (Section D): ETHICON, INC.; route 22 west; p.o. box 151; somerville NJ 08876
• MDR Report Key: 7435691
• MDR Text Key: 105686690
• Report Number: 7435691
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/06/2018

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
• Device Model Number: 810081
• Device Catalogue Number: 810081
• Device Lot Number: 3518474
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/06/2018
• Device Age: 7 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/06/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Weight: 71