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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Cyst(s) (1800); Purulent Discharge (1812); Emotional Changes (1831); Fever (1858); Fistula (1862); Foreign Body Reaction (1868); Micturition Urgency (1871); Hemorrhage/Bleeding (1888); Incontinence (1928); Unspecified Infection (1930); Inflammation (1932); Nausea (1970); Pain (1994); Scar Tissue (2060); Sepsis (2067); Urinary Retention (2119); Urinary Tract Infection (2120); Peritonitis (2252); Urinary Frequency (2275); Discomfort (2330); Impaired Healing (2378); Prolapse (2475); Hematuria (2558); Abdominal Distention (2601); Dysuria (2684); Fibrosis (3167); Constipation (3274); Cramp(s) /Muscle Spasm(s) (4521); Nodule (4551); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative
(b)(4). 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 uterine prolapse and vaginal vault prolapse. It was reported that after the implant, the patient experienced disability, emotional changes, inflammation, bladder cysts, vaginal wall mass, bladder infection, chronic constipation, diverticulitis, rectocele, cystocele, urinary incontinence, urinary retention, pelvic tumors or fibroids, vaginal infections, uterine prolapse, vaginal vault prolapse, adhesions, dyspareunia, peritonitis/sepsis, vaginal pain, pain during sexual intercourse, cramping, wound healing problems, scarring, pus, flesh hanging out from the scar, bleeding/clotting disorders, discomfort, post coital bleeding, pain, bulging, nocturia, urinary urgency, hypermobility of bladder neck, hematuria, and fistulas. Post-operative patient treatment included revision surgeries, medication including nerve blocks, caesarean birth, cystoscopy, vaginal hysterectomy, anterior and posterior repair, removal of posterior vaginal wall mass/posterior vaginal repair, urethral dilation and mesh removal surgery.
 
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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
justin ellis
5920 longbow drive
8200 coral sea st ne
mounds view,mn, CO 55112
7635265677
MDR Report Key14459639
MDR Text Key292206893
Report Number6000141-2022-00020
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,Followup
Report Date 09/27/2022
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 Model NumberIVS01
Device Catalogue NumberIVS01
Was Device Available for Evaluation? No
Date Manufacturer Received09/07/2022
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: 05/20/2022 Patient Sequence Number: 1
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