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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 IVS02
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Adhesion(s) (1695); Erosion (1750); Emotional Changes (1831); Erythema (1840); High Blood Pressure/ Hypertension (1908); Incontinence (1928); Unspecified Infection (1930); Muscle Weakness (1967); Pain (1994); Perforation (2001); Urinary Retention (2119); Anxiety (2328); Distress (2329); Discomfort (2330); Prolapse (2475); Constipation (3274); Sexual Dysfunction (4510); Nodule (4551); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Event Description
The patient¿s attorney alleged a deficiency against the device. The product was used for therapeutic treatment of cystocele, rectocele, urinary incontinence, urinary retention, vaginal vault prolapse. It was reported that after implant, the patient experienced chronic constipation, ibs, rectocele, urinary incontinence, recurrent prolapse, pulling type feeling, dyspareunia, vaginal vault prolapse, cysotcele, unable to have sexual intercourse, recurrent vaginal pain, adhesions, hypertension, anxiety, stress, pain, severe feelings of frustration, limited physical activities, urinary retention, vaginal pressure, vaginal lump, weak pelvic floor muscle tone, erythema, infection, vaginal wall erosion, mesh protrusion, generalized atrophy. Post-operative patient treatment included repair of mesh, cystoscopy, partial removal of mesh, additional surgery, additional implant, and medication.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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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 Key14462964
MDR Text Key292401482
Report Number6000141-2022-00029
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeMC
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 05/20/2022
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 Date08/31/2007
Device Model NumberIVS02
Device Catalogue NumberIVS02
Device Lot Number04H109
Was Device Available for Evaluation? No
Date Manufacturer Received05/04/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/31/2004
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
Treatment
SURGISIS ES (RECTOCELE) (PRODUCT ID: J-SLH-4S-7X10
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