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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); Anemia (1706); Bacterial Infection (1735); Erosion (1750); Diarrhea (1811); Emotional Changes (1831); Foreign Body Reaction (1868); Hemorrhage/Bleeding (1888); High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914); Incontinence (1928); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Perforation (2001); Urinary Retention (2119); Urinary Tract Infection (2120); Urinary Frequency (2275); Distress (2329); Discomfort (2330); Prolapse (2475); Weight Changes (2607); Intermenstrual Bleeding (2665); Dysuria (2684); Fibrosis (3167); Constipation (3274); Sexual Dysfunction (4510); 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. It was reported that after implant, the patient experienced chronic constipation, bowel going through vaginal wall, diarrhea, bowel prolapse, crohn's disease, enterocele, rectocele, difficulties with bowel motions, chronic vaginal and bladder infections with utis, urinary incontinence, fecal incontinence, urinary retention, uterine prolapse, vagina collapsed, bowel and bladder near opening of vagina, dyspareunia, psychiatric injury, recurrent vaginal pain, painful intercourse, unable to have sexual intercourse, sexual intercourse associated with urine/faeces/wind incontinence, cystocele, erosion, extrusion, protrusion, adhesions, vaginal bleeding, feeling of rubbing inside vagina, anemia, hypertension, hypotension, obesity, pain, weight gain, unable to exercise, severe feelings of frustration, severe emotional health, and distress. Post-operative patient treatment included laxatives, iron infusions, hysterectomy, additional surgery, partial removal of mesh, daily physiotherapy, pain medication, otc analgesics, bladder repair, appendectomy, pristiq, lithium, and largactil.
 
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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 Key14459592
MDR Text Key292207059
Report Number6000141-2022-00024
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
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,Followup
Report Date 09/23/2022
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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