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

Model Number 482068

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Incontinence (1928); Injury (2348); Prolapse (2475); No Code Available (3191)

Event Date 07/01/2003

Event Type  Injury  

Manufacturer Narrative

Initial reporter occupation: attorney (atty).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.Product was used for therapeutic treatment.Patient underwent mesh implant surgery for cystocele and rectocele.The postoperative complications that this patient developed following transvaginal placement of surgical mesh is that in 2003 patient had to undergo cystoscopy, cystocele repair, pubovaginal sling for cystocele and rectocele.Complications post pubovaginal sling placement in 2013: patient presents for pelvic organ prolapse and urinary incontinence.Patient underwent additional surgery in 2013 for sacrospinous vaginal vault suspension, rectocele repair and monarc mid urethral sling and cystoscopy for symptomatic post-hysterectomy vaginal vault prolapse.

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: 7715641
• MDR Text Key: 114884806
• Report Number: 9617613-2018-00071
• 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: 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: 07/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 482068
• Device Catalogue Number: 482068
• Device Lot Number: 02A20B590077
• 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
• Patient Age: 60 YR