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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 Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erosion (1750); Micturition Urgency (1871); Incontinence (1928); Pain (1994); Scarring (2061); Urinary Retention (2119); Myalgia (2238); Urinary Frequency (2275); Injury (2348); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: ivs02(lot#:0302040-24), gpsl gynecare gynemesh (lot# spe302). (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 symptomatic pelvic relaxation, stress urinary incontinence. It was reported that after implant, the patient experienced dyspareunia, vaginal pain, urinary urgency, urinary frequency, difficulty emptying bladder, severe pain in buttock region, bladder pain, nocturia, urge incontinence, levator muscle pain, scarring, mesh tape sling on quite a bit of tension, mesh extrusion of the posterior wall near introitus, and exposed portion of mesh. Post-operative patient treatment included surgical intervention. The device had been used with gpsl gynecare gynemesh, lot# spe302.
 
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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 Key8899716
MDR Text Key154545553
Report Number6000141-2019-00013
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 consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 08/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/15/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2006
Device Model NumberIVS02
Device Catalogue NumberIVS02
Device Lot Number0302040-24
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/17/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/01/2003
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: 08/15/2019 Patient Sequence Number: 1
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