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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); No Apparent Adverse Event (3189)
Patient Problems Pain (1994); Scarring (2061); Injury (2348); No Code Available (3191)
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 resulting in an unspecified adverse outcome. Product was used for therapeutic treatment. The reason for mesh implantation was vaginal prolapse with cystocele, enterocele and rectocele. The patient reported experiencing pelvic pain, constant lower back pain, scar tissue, unable to stand for more than 10 minutes, problems with walking, pain, constant daily pain limits regular activities like yard work, cleaning, loss of sexual interest, pain, continual emotional sadness and bladder issues. Interventional surgery required.

 
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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 Key7658797
MDR Text Key113034786
Report Number6000141-2018-00016
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK073164
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation ATTORNEY
Type of Report Initial
Report Date 07/03/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/03/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/31/2006
Device MODEL NumberIVS02
Device Catalogue NumberIVS02
Device LOT Number0302040-04
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/06/2018
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: 07/03/2018 Patient Sequence Number: 1
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