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

Model Number IVS02

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Abscess (1690); Pain (1994); Burning Sensation (2146); Cramp(s) (2193); Discomfort (2330); Numbness (2415); Prolapse (2475); Blood Loss (2597)

Event Date 06/06/2008

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer stated that the unit caused them to have persistent pelvic pain and declining health.According to customer, pelvic pain, leg pain and burning sensations of upper legs and knees.Numbness on the groin area and buttocks after sitting for any length.Loss of intimacy within marriage due to discomfort in pelvic and groin area.Bloating of stomach and constant pain such as period cramping pain.Lower back pain and joint pain.Poor sleep routine.Occasional bleeding from the vagina even though a vaginal hysterectomy 1994.The tvt was implanted 2008.Unable to walk for long periods which has affected the patient's work.The patient's health has deteriorated over the past 5 or 6 years and all issues have been investigated via urine, blood, and x-rays which have mainly come back negative.

Manufacturer Narrative

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

• Brand Name: MESH BALLYMONEY - IVS TUNNELLER¿
• Type of Device: MESH, 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 Key: 7321495
• MDR Text Key: 101790597
• Report Number: 6000141-2018-00001
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K010035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IVS02
• Device Catalogue Number: IVS02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/07/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other