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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 Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Abdominal Pain (1685); Autoimmune Disorder (1732); Erosion (1750); Bradycardia (1751); Emotional Changes (1831); Foreign Body Reaction (1868); Low Blood Pressure/ Hypotension (1914); Incontinence (1928); Nausea (1970); Pain (1994); Tachycardia (2095); Urinary Tract Infection (2120); Urinary Frequency (2275); Injury (2348); Loss of consciousness (2418); Sweating (2444); Diaphoresis (2452); Pallor (2468); Prolapse (2475); Vaso-Vagal Response (2661); No Code Available (3191); Unspecified Tissue Injury (4559)
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 stress urinary incontinence and cystocele. It was reported that after implant, the patient experienced chronic suprapubic/vaginal pain and dyspareunia. Post-operative treatment included removal of the device. The removal did not alleviate these issues.
 
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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 Key9883806
MDR Text Key191399886
Report Number6000141-2020-00003
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K073164
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 01/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/26/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/30/2007
Device Model NumberIVS02
Device Catalogue NumberIVS02
Device Lot Number04E109
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/26/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/30/2004
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: 03/26/2020 Patient Sequence Number: 1
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