• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TYCO HEALTHCARE UK MANF. LTD MESH BALLYMONEY - IVS TUNNELLER¿ MESH, SURGICAL, POLYMERIC

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

TYCO HEALTHCARE UK MANF. LTD MESH BALLYMONEY - IVS TUNNELLER¿ MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number UNKNOWN IVS
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Erosion (1750); Unspecified Infection (1930); Pain (1994); Abnormal Vaginal Discharge (2123); Injury (2348); Prolapse (2475); Blood Loss (2597); Foreign Body In Patient (2687); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative

(b)(4). A good faith effort will be made to obtain the applicable information relevant to the report. 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 preoperative and postoperative diagnosis was genuine urine stress incontinence and complex uterovaginal prolapse. The procedure performed was a laparoscopic assisted vaginal hysterectomy, bilateral salpingooophorectomy, a left ureterolysis with bilateral sacrospinous fixation, neovagina with graft, tvt, sling and urethropexy and a cystoscopy with calibration. On (b)(6) 2005 the patient returned for vaginal secretions. Between (b)(6) 2005 the patient complained of heavy vaginal discharge. On (b)(6) 2005 an erosion of graft at apex of vagina was trimmed. The assessment was incomplete uterovaginal prolapse and erosion of graft at anterior vagina. On (b)(6) 2005 the patient presented with vaginal graft erosion. The patient underwent an additional procedure on (b)(6) 2005. The reason for surgery was vaginal graft erosion. The procedure performed was a revision of the graft. Between (b)(6) 2006 the patient complained of vaginal spotting and lower abdominal pain x2 weeks, sensation of incomplete emptying, strong flow of urine stream, and vaginal infection and pain at the graft site. On (b)(6) 2006 the patient complained of vaginal pain and bleeding since surgery. On examination it showed graft erosion. The patient underwent an additional procedure on (b)(6) 2006. The reason for surgery was graft erosion. The procedure performed was a graft revision, vaginal advancement flap, and removal of foreign body.

 
Manufacturer Narrative

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

 
Manufacturer Narrative

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

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 avenue
north haven, CT 06473
2034925563
MDR Report Key6394999
MDR Text Key69621358
Report Number6000141-2017-05005
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,Followup,Followup
Report Date 04/26/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/10/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberUNKNOWN IVS
Device Catalogue NumberUNKNOWN IVS
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 Received05/09/2017
Was Device Evaluated By Manufacturer? No
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: 03/10/2017 Patient Sequence Number: 1
-
-