MAUDE Adverse Event Report: TISSUE SCIENCE LABORATORIES MESH TSL - PELVICOL¿; MESH, SURGICAL, POLYMERIC

Model Number 482047

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

Patient Problems Cyst(s) (1800); Micturition Urgency (1871); Incontinence (1928); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Discharge (2225); Urinary Frequency (2275); Injury (2348); Prolapse (2475); Hematuria (2558); Blood Loss (2597); Dysuria (2684); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Medtronic complaint report: (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.Reason for mesh implantation: very large cystocele, vaginal wall prolapse, rectocele and stress urinary incontinence.Procedures performed: cystoscopy, tension free suspension, anterior repair, exploratory laparotomy, gortex colposacral suspension.Concomitant implants (products used at the same time): gynecare tvt device.Complications post additional implant surgery: complains of vaginal bulging out and possible urinary tract infection (uti), pelvic pressure and odorous urine, dysuria, bleeding with intercourse, mild rectocele.Cystoscopy, vaginoscopy, examination under anesthesia revealed ¿bladder: has changes of cystitis cystica at bladder neck, orifices are normal.No stones, tumors, or foreign bodies were noted throughout the bladder.Cystitis, vaginitis, urinary tract infection, bladder spasm and increased pressure with micturition, malodorous urine, cloudy urine, dysuria and frequency.Pain since bladder repair, pelvic pain, dyspareunia and frequent urinary tract infections (uti), urinary incontinence, pelvic organ prolapse, post menopausal atrophic vaginitis, fecal incontinence.Interventional surgery: (b)(6) 2014: underwent cystoscopy and exam under anesthesia for incomplete emptying with history of multiple urethral slings under general anesthesia.Conditions post interventional surgery: bladder and pelvic pressure, incomplete emptying, micro hematuria, positive for urinary leakage, incomplete emptying, microhematuria and recurrent uti, stress incontinence, micro hematuria, urinary retention and benign neoplasm bladder.On (b)(6) 2015: underwent interstim percutaneous sacral nerve stimulation test with fluoroscopic guidance for needle placement.Repeat procedure on the opposite side of the sacral nerve for incomplete emptying and fecal incontinence under local anesthesia.Bladder pain.Assessed with incomplete emptying and bladder pain.

Manufacturer Narrative

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.The product was used for therapeutic treatment.The reason for mesh implantation was a very large cystocele, vaginal wall prolapse, rectocele and stress urinary incontinence.The procedures performed were cystoscopy, tension free suspension, anterior repair, exploratory laparotomy, gortex and colpo sacral suspension.The complications post additional implant surgery were urinary tract infection (uti), pelvic pressure, odorous urine, dysuria, bleeding with intercourse and mild rectocele.

• Brand Name: MESH TSL - PELVICOL¿
• 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: 7396755
• MDR Text Key: 104361172
• Report Number: 9617613-2018-00020
• 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,Followup
• Report Date: 06/21/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/21/2002
• Device Model Number: 482047
• Device Catalogue Number: 482047
• Device Lot Number: 01A04B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/03/2016
• Initial Date FDA Received: 04/04/2018
• Supplement Dates Manufacturer Received: 07/05/2017
• Supplement Dates FDA Received: 06/21/2018
• 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: 41 YR