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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); Bacterial Infection (1735); Erosion (1750); Purulent Discharge (1812); Inflammation (1932); Necrosis (1971); Neuropathy (1983); Pain (1994); Scarring (2061); Abnormal Vaginal Discharge (2123); Injury (2348); Fungal Infection (2419); Blood Loss (2597); Foreign Body In Patient (2687); 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. The product was used for therapeutic treatment. It was reported that after 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 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 Key9290744
MDR Text Key165471270
Report Number6000141-2019-00020
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,Followup,Followup
Report Date 07/30/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/07/2019
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 Number0302040-24
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/15/2020
Was Device Evaluated By Manufacturer? No Answer Provided
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: 11/07/2019 Patient Sequence Number: 1
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