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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 Abscess (1690); Erosion (1750); Cyst(s) (1800); Purulent Discharge (1812); Micturition Urgency (1871); Hemorrhage/Bleeding (1888); Incontinence (1928); Unspecified Infection (1930); Nerve Damage (1979); Neuropathy (1983); Pain (1994); Scar Tissue (2060); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Burning Sensation (2146); Urinary Frequency (2275); Injury (2348); Prolapse (2475); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative

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 urinary stress incontinence. It was reported that after the implant, the patient experienced an unspecified adverse outcome.

 
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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 GU11 1EJ
GB GU11 1EJ
Manufacturer (Section G)
TYCO HEALTHCARE UK MANF. LTD
20 garryduff road             
ballymoney,at GU11 1EJ
GB GU11 1EJ
Manufacturer Contact
lisa hernandez
60 middletown ave.
north haven, CT 06473
2034925563
MDR Report Key10260371
MDR Text Key200040290
Report Number9617613-2020-00061
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
Type of Report Initial,Followup
Report Date 01/06/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/10/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/30/2007
Device MODEL NumberIVS02
Device Catalogue NumberIVS02
Device LOT Number04F109
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/09/2020
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: 07/10/2020 Patient Sequence Number: 1
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