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

Model Number IVS02

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

Patient Problems Abdominal Pain (1685); Erosion (1750); Menstrual Irregularities (1959); Pain (1994); Uterine Perforation (2121); Abnormal Vaginal Discharge (2123); Injury (2348); Prolapse (2475); Blood Loss (2597); Heavier Menses (2666); No Code Available (3191)

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 resulting in an unspecified adverse outcome.Product was used for therapeutic treatment.Preoperative and postoperative diagnosis was urinary stress incontinence.­­­­­­­­­the procedure performed was tension-free vaginal tape.Aprox.3 years post op, the patient underwent a procedure for total vaginal hysterectomy, bilateral salp [ingo-oophorectomy, uterosacral ligament suspension and intraoperative cystoscopy and left vaginal sidewall lesion excision.The preoperative diagnosis was symptomatic severe uterine prolapse, grade 3-4 undesired fertility, patient requesting definitive operative intervention including bilateral salpingo-oophorectomy, pelvic pain, dyspareunia and dysfunctional uterine bleeding and menorrhagia.Aprox.3 years 8 months post op, the patient underwent a procedure for cystoscopy and vaginoscopy.Aprox.3 year 9 months post op, the patient underwent a procedure for a vaginal and suprapubic exploration and excision of tension free transvaginal mesh and intraoperative cystoscopy.The preoperative and postoperative was vaginal mesh erosion with pelvic pain and chronic discharge.Past surgical history: total abdominal hysterectomy, bilateral salpingo-oophorectomy this past january, transvaginal taping 3 years ago.Ob history: 2 vaginal deliveries.Social history: 20-pack-year smoking and rarely drinks any alcohol.

• 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: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 7014853
• MDR Text Key: 91520092
• Report Number: 6000141-2017-05016
• 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: other
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 11/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2009
• Device Model Number: IVS02
• Device Catalogue Number: IVS02
• Device Lot Number: 06A068
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/11/2017
• Date Device Manufactured: 01/01/2006
• 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: 45 YR