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 Micturition Urgency (1871); Pain (1994); Urinary Frequency (2275); Injury (2348); Prolapse (2475)

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.Reason for mesh implantation: stress type incontinence, vaginal vault prolapse with symptomatic cystocele/rectocele and enterocele.Procedure (s) performed: sling trans-obturator tape obtryx procedure, posterior colporrhaphy with enterocele repair with pelvisoft placement, vaginal vault suspension with ivs tunneller, anterior colporrhaphy.Complications post ivs tunneller and pelvisoft placement: in, 2012 - frequency of urination, urgency, incomplete emptying, posterior vaginal wall prolapse, grade 1 degree of apical vaginal prolapse and grade 1 degree of anterior vaginal wall prolapse - scheduled for graft augmented rectocele repair, vaginal vault suspension with correction of cystocele, mid-urethral sling procedure revision via trans-obturator approach and cystoscopy.

Manufacturer Narrative

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

• 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: 7682602
• MDR Text Key: 113807263
• Report Number: 6000141-2018-00019
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K010035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2007
• Device Model Number: IVS02
• Device Catalogue Number: IVS02
• Device Lot Number: 04J169
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 10/01/2004
• 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: 38 YR