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

Model Number 482027

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

Patient Problems Fistula (1862); Incontinence (1928); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Injury (2348); Numbness (2415); Prolapse (2475); Ambulation Difficulties (2544); Hematuria (2558); No Code Available (3191); Constipation (3274)

Event Type  Injury  

Manufacturer Narrative

(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. The product was used for therapeutic treatment of second degree cystocele. It was reported that after implant, the patient experienced uterine prolapse, vaginal and vaginal vault prolapse, stress urinary incontinence, with urethral hypermobility, right ureterolysis, abdominal enterocele, rectocele, cervical prolapse, pain, urinary problems, bowel problems, fistulae, recurrence, dyspareunia, recurrent cystocele, urinary tract infections, urinary retention, self-catheterization, nocturia, incomplete stool emptying, straining for urination, dribbling, hematuria, numbness in the left thigh and left vulva, perineal numbness, constipation, vaginal pain, difficulty initiating stream, bladder spasms, discomfort walking and standing due to fallen bladder, and vaginitis. Post-operative patient treatment included surgical and nonsurgical interventions, including hysterectomy.

• Brand Name: 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: 9260983
• MDR Text Key: 166795997
• Report Number: 9617613-2019-00182
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 04/09/2012
• Device Model Number: 482027
• Device Catalogue Number: 482027
• Device Lot Number: 08B21-8
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/06/2019
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 10/31/2019 Patient Sequence Number: 1