MAUDE Adverse Event Report: TISSUE SCIENCE LABORATORIES UNKNOWN MESH; MESH, SURGICAL, POLYMERIC

Model Number UNKNOWN MESH

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Incontinence (1928); Pain (1994); Urinary Tract Infection (2120); Injury (2348); Prolapse (2475); Hematuria (2558); Blood Loss (2597); No Code Available (3191); Constipation (3274)

Event Type  Injury  

Manufacturer Narrative

This incident was originally reported on (b)(6) 2015 as an asr report for product id uretexto2.Ref: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

The patient's attorney alleged a deficiency against the device resulting in an unspecified adverse outcome.Product was used for therapeutic treatment.The reason/ indication for mesh implantation: postmenopausal right ovarian cyst, pelvic pain, stress incontinence, symptomatic rectocele.The procedure performed: diagnostic laparoscopy, bilateral salpingo-oophorectomy, transvaginal tape, posterior repair with mesh, posterior ivs.Concomitant implants: sling, tyco, tvt exact sling, biodesign.Postoperative complications: (b)(6) 2005: underwent uretex, transvaginal tape (pelvitex), posterior repair with mesh (ivs) along with diagnostic laparoscopy and bilateral salpingo-oophorectomy under general anesthesia.On (b)(6) 2005: the patient reported a ¿cutting¿ sensation when urinating.On (b)(6) 2008: underwent examination, excision of posterior vaginal mesh and partial vaginectomy under general anesthesia for mesh protruding through posterior vaginal mucosa.Following mesh revision surgery patient had complications such as mesh erosion, malodorous discharge, mixed urinary incontinence, voiding dysfunction, fecal incontinence (fi) and constipation ¿ dr.(b)(6) in 2006 for mesh removal.In-office trimming: in 2011 for erosion.Urinary tract infections, mesh extrusion, stage ii cystocele, vaginal bleeding, back pain, pain with intercourse during the interim period (b)(6) 2012- (b)(6) 2014 and underwent the following additional surgeries.On (b)(6) 2012: second mesh revision along with first additional implant (tvt exact) surgery: underwent anterior colporrhaphy, tvt exact sling, cystoscopy and excision of posterior vaginal wall mesh extrusion, relaxing incisions at mid vagina bilateral under general anesthesia for posterior wall vaginal mesh extrusion, urodynamic stress incontinence, stage ii cystocele.On (b)(6) 2014: third mesh revision along with second additional implant (biodesign) surgery: underwent excision of posterior vaginal wall mesh, posterior colporrhaphy and perineorrhaphy with xenograft augmentation (biodesign by cook), perineorrhaphy, cysto urethroscopy under generalanesthesia for recurrent mesh extrusion after previous mesh prolapse procedure, hematuria.Ref: (b)(4).

• Brand Name: UNKNOWN MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): TISSUE SCIENCE LABORATORIES; victoria house, victoria road; aldershot, hampshire GU11 1EJ; GB GU11 1EJ
• Manufacturer (Section G): TISSUE SCIENCE LABORATORIES; victoria house, victoria road; aldershot, hampshire GU11 1EJ; GB GU11 1EJ
• Manufacturer Contact: lisa hernandez ; 60 middletown ave; north haven, CT 06473 ; 2034925563
• MDR Report Key: 7547288
• MDR Text Key: 109356795
• Report Number: 9617613-2018-00040
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 05/27/2018

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: Health Professional
• Device Expiration Date: 07/30/2007
• Device Model Number: UNKNOWN MESH
• Device Catalogue Number: UNKNOWN MESH
• Device Lot Number: 04G199
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/26/2015
• Initial Date FDA Received: 05/27/2018
• Date Device Manufactured: 07/01/2004
• 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
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 60 YR