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

Model Number UNK PELVICOL

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

Patient Problems Failure of Implant (1924); Incontinence (1928); Abnormal Vaginal Discharge (2123); Injury (2348); Prolapse (2475); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter: the patient alleged injury. Patient underwent pelvicol reconstruction in 2006. Corresponding operative report is not available to know the details of the operation performed. Complications post pelvicol placement in 2006: recurrent stress incontinence and pelvic prolapse with a history of previous pelvicol reconstruction. Indirect information taken from the operative report. First additional implant surgery: 2006: underwent urethrolysis, sling, anterior repair, and sacrospinous fixation for recurrent stress incontinence and pelvic prolapse under general anesthesia complications post additional implant surgery: 2006: stress urinary incontinence and pelvic prolapse. (indirect information taken from the operative report; corresponding medical records are not available to substantiate these complications). Mesh revision surgery with second additional implant surgery: 2006: underwent sling, anterior repair, posterior repair and sacrospinous fixation of pelvic prolapse for stress urinary incontinence and pelvic prolapse under general anesthesia. Following mesh revision patient developed vaginal discharge, recurrent stress incontinence and pelvic prolapse during the time period from 2006 to 2007 and underwent the following surgeries. Interventional surgery: 2006: underwent cystoscopy, removal of foreign body and closure of vagina for history of pelvic prolapse with previous multiple procedures with vaginal discharge. Third additional implant surgery:2007: underwent sling, urethrolysis, anterior repair with graft, sacrospinous fixation and cystoscopy for recurrent stress incontinence and pelvic prolapse under general anesthesia. Concomitant therapy: pelvilace to trans-obturator biourethral support system with hook needle, uretex to2 urethral support system w/hook needle, pelvitex polypropylene mesh, avaulta posterior biosynthetic support system precision twist transvaginal anchor.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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: 7745098
• MDR Text Key: 115904289
• Report Number: 9617613-2018-00075
• 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,other

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: UNK PELVICOL
• Device Catalogue Number: UNK PELVICOL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/08/2018
• 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: 08/02/2018 Patient Sequence Number: 1