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

Model Number 482027

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Hemorrhage/Bleeding (1888); Incontinence (1928); Menstrual Irregularities (1959); Pain (1994); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Discharge (2225); Urinary Frequency (2275); Injury (2348); Disability (2371); Dysuria (2684); No Code Available (3191); Constipation (3274)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported by the patient's attorney that as a result of having the product implanted, the patient has experienced injury, pain, disability and impairment.Product was used for therapeutic treatment.The indication for implantation of transvaginal mesh in this patient is urinary stress incontinence.The postoperative complications that this patient developed following transvaginal placement of surgical mesh.In 2002: underwent transvaginal bladder sling procedure (with pelvicol) under general anesthesia.Complications post (pelvicol) implantation: in 2002: had bladder sling shifted, vaginal bleeding during intercourse, constipation, abnormal menses, vaginal dryness and discharge.Assessed with bladder suspension.In 2002: had previous urinary stress incontinence procedure that seemed to fail after the patient had fallen.Assessed with urinary stress incontinence.Scheduled for transvaginal bladder sling (indirect information taken from the operative report dated (b)(6) 2002) additional implant (with pelvicol) surgery details: 2002: underwent transvaginal bladder sling (with pelvicol) for urinary stress incontinence under general anesthesia.Complications post additional mesh implant surgery: (interim medical records from 2002 ¿ 2005 were not available for review) as on 2005: had urgency incontinence and urinary frequency.Scheduled for cystoscopy, urethral dilation, and removal of suture conditions post interventional surgery: had vaginal pain, painful intercourse, urinary tract infection (corresponding medical records were not available to substantiate these complications) mesh revision surgery: (b)(6) 2013: had vaginal pain and dyspareunia; pelvic mesh was removed in (b)(6) 2013 by dr.(b)(6) at (b)(6) hospital because patient was in a lot of pain and was experiencing painful intercourse but records further to (b)(6) 2005 were not available to substantiate these complications.

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: 7745158
• MDR Text Key: 115900206
• Report Number: 9617613-2018-00076
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K992556
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/04/2018

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: Health Professional
• Device Model Number: 482027
• Device Catalogue Number: 482027
• Device Lot Number: 01A11B520079
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• 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: 32 YR