MAUDE Adverse Event Report: TYCO HEALTHCARE UK MANF. LTD MESH BALLYMONEY - IVS TUNNELLER¿; MESH, SURGICAL, POLYMERIC

Model Number IVS03

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

Patient Problems Micturition Urgency (1871); Irritation (1941); Pain (1994); Scarring (2061); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Urinary Frequency (2275); Injury (2348); Depression (2361); Prolapse (2475); Hematuria (2558); Blood Loss (2597); Dysuria (2684); Constipation (3274)

Event Type  Injury  

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.Product was used for therapeutic treatment of a metro-menorrhagia, pelvic prolapse, and stress urinary incontinence.The device was implanted during a laparoscopic-assisted total vaginal hysterectomy.The procedure included bilateral sacrospinous fixation using ivs tunneller, posterior repair, and pubovaginal sling using the ivs tunneller sling.Post-procedure complications included vaginal bleeding, bleeding with urine, tenderness in the area of the posterior repair, urinary urgency, irritable bladder symptoms, urinary tract infection, dysuria, and urinary frequency.After surgical treatment of the symptoms, the patient continued to experience stress incontinence, prolapse of vaginal walls, hematuria, dysuria, urinary tract infection and small graft anterior erosion.After a third mesh revision surgery and other surgical treatment for the symptoms, the patient experienced urinary frequency, dysuria, urine leakage, urinary hesitancy, incomplete voiding, increased bladder sensation, rectal bleeding, protrusion out of the anal canal and chronic constipation, left lower abdominal pain, hemorrhoids, recurrent uti, proteinuria, hematuria, bladder outlet obstruction, supra-pubic pain, pain with intercourse, irritative voiding symptoms, uti, bladder disorder, and stress incontinence.After a fourth surgery, the patient reported depression, anxiety, scarring, currently having pacemaker on bladder, bowel perforation, and retention.

• Brand Name: MESH BALLYMONEY - IVS TUNNELLER¿
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): TYCO HEALTHCARE UK MANF. LTD; 20 garryduff road ; ballymoney,at BT53 7AP ; GB BT53 7AP
• Manufacturer (Section G): TYCO HEALTHCARE UK MANF. LTD; 20 garryduff road ; ballymoney,at BT53 7AP ; GB BT53 7AP
• Manufacturer Contact: lisa hernandez ; 60 middletown ave; north haven, CT 06473 ; 2034925563
• MDR Report Key: 7643211
• MDR Text Key: 112512149
• Report Number: 6000141-2018-00012
• 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
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2006
• Device Model Number: IVS03
• Device Catalogue Number: IVS03
• Device Lot Number: 04B129
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/03/2017
• 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: 35 YR