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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 IVS01
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Adhesion(s) (1695); Bacterial Infection (1735); Erosion (1750); Emotional Changes (1831); Micturition Urgency (1871); Incontinence (1928); Unspecified Infection (1930); Itching Sensation (1943); Pain (1994); Perforation (2001); Urinary Tract Infection (2120); Burning Sensation (2146); Urinary Frequency (2275); Discomfort (2330); Fungal Infection (2419); Obstruction/Occlusion (2422); Prolapse (2475); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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. The product was used for therapeutic treatment of cystocele, uterine prolapse, vaginal vault prolapse and rectum prolapse. It was reported that after the implant, the patient experienced prolapse, diverticulitis, difficulties with bowel motions, some loss of control of bowel and bladder, urinary incontinence, cystitis thrush, utis, pelvic trauma/prolapse, discomfort, infection, uterine prolapse, vaginal vault prolapse, sexual intercourse reported with urinary incontinence, disability, emotional changes, recurrent prolapse, erosion, protrusion and extrusion of mesh, escherichia coli/mixed organisms, pain, mesh exposure, vaginal thrush, urinary urgency, infections, vaginal dryness, overactive bladder, urinary frequency, burning sensation, itching, vaginal atrophy, vaginal candiasis, nocturia, obstruction when standing, and adhesions. Post-operative patient treatment included colonoscopies, medication, physiotherapy, removal of mesh, urethral dilation, and cystoscopy.
 
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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 
UK BT53 7AP 
Manufacturer (Section G)
TYCO HEALTHCARE UK MANF. LTD
20 garryduff road             
ballymoney,at BT53 7AP 
UK BT53 7AP 
Manufacturer Contact
tracy landers
5920 longbow drive
boulder, CO 80301
3035816943
MDR Report Key14459544
MDR Text Key292206404
Report Number6000141-2022-00025
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 05/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/20/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2005
Device Model NumberIVS01
Device Catalogue NumberIVS01
Device Lot Number0210030-03
Was Device Available for Evaluation? No
Date Manufacturer Received05/04/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/31/2002
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: 05/20/2022 Patient Sequence Number: 1
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