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U.S. Department of Health and Human Services

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

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TYCO HEALTHCARE UK MANF. LTD MESH BALLYMONEY - IVS TUNNELLER¿ MESH, SURGICAL, POLYMERIC Back to Search Results
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.
 
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Brand NameMESH BALLYMONEY - IVS TUNNELLER¿
Type of DeviceMESH, 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 Key7643211
MDR Text Key112512149
Report Number6000141-2018-00012
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K992556
Number of Events Reported1
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 Received06/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/01/2006
Device Model NumberIVS03
Device Catalogue NumberIVS03
Device Lot Number04B129
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/03/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/27/2018 Patient Sequence Number: 1
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