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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BALLYMONEY - USS UNKNOWN IVS TUNNELLER DEVICE MESH, SURGICAL, POLYMERIC

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BALLYMONEY - USS UNKNOWN IVS TUNNELLER DEVICE MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problems Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Inflammation (1932); Pain (1994); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Injury (2348); Dysuria (2684); Patient Problem/Medical Problem (2688)
Event Date 07/12/2006
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

The patient's attorney alleged a deficiency against the device resulting in an unspecified adverse outcome. Product was used for therapeutic treatment.

 
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
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Brand NameUNKNOWN IVS TUNNELLER DEVICE
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
BALLYMONEY - USS
20 garryduff road
ballymoney co.
antrim
EI
Manufacturer (Section G)
BALLYMONEY - USS
20 garryduff road
ballymoney co.
antrim
EI
Manufacturer Contact
lisa hernandez
60 middletown ave
north haven 
34925563
MDR Report Key5984740
MDR Text Key55872953
Report Number6000141-2016-00009
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,FOREIGN
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/04/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/28/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
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 Received08/08/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 09/28/2016 Patient Sequence Number: 1
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