MAUDE Adverse Event Report: ETHICON INC. TENSION FREE VAGINAL TAPE - SECUR UNKNOWN PRODUCT; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL

Catalog Number TVTSECUNK

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Erosion (1750); Incontinence (1928); Pain (1994); Urinary Tract Infection (2120); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported via journal article, ¿minimally invasive procedure for the treatment of primary stress urinary incontinence¿ that a study was conducted to evaluate the efficacy and morbidity of the new minimally invasive mesh procedure in the treatment of primary stress urinary incontinence (sui).The study design was a prospective multi-centre trial involving 4 different hospitals.All patients with primary urodynamic sui and urethral hypermobility were prospectively selected to receive the procedure.Each centre was allowed to perform the procedure either in the ¿hammock¿- or ¿u¿-shaped approach.From november 2006 to september 2007, 95 consecutive patients (mean age 57+/-10 years [range 36-79]; median parity 2 [range 0-6]; median bmi 27.1+/-5 kg/m2) were enrolled in the study.Postoperative complications include: voiding difficulty (n=7), recurrent urinary tract infection (n=9), de novo urgency incontinence (n=9), dyspareunia for a defect healing with vaginal protrusion of the mesh (n=2).The tvt-secur procedure seems to be an effective treatment for women with primary sui with an overall success rate of 80%.

Manufacturer Narrative

Date sent to: 9/4/2019.

• Brand Name: TENSION FREE VAGINAL TAPE - SECUR UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20; neuchatel ; SZ
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville 08876-0151 ; 9082182792
• MDR Report Key: 7096917
• MDR Text Key: 94152006
• Report Number: 2210968-2017-71666
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• PMA/PMN Number: K052401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: TVTSECUNK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1