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

Model Number IVS02

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Adhesion(s) (1695); Erosion (1750); Emotional Changes (1831); Erythema (1840); High Blood Pressure/ Hypertension (1908); Incontinence (1928); Unspecified Infection (1930); Muscle Weakness (1967); Pain (1994); Perforation (2001); Urinary Retention (2119); Anxiety (2328); Distress (2329); Discomfort (2330); Prolapse (2475); Constipation (3274); Sexual Dysfunction (4510); Nodule (4551); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of cystocele, rectocele, urinary incontinence, urinary retention, vaginal vault prolapse.It was reported that after implant, the patient experienced chronic constipation, ibs, rectocele, urinary incontinence, recurrent prolapse, pulling type feeling, dyspareunia, vaginal vault prolapse, cysotcele, unable to have sexual intercourse, recurrent vaginal pain, adhesions, hypertension, anxiety, stress, pain, severe feelings of frustration, limited physical activities, urinary retention, vaginal pressure, vaginal lump, weak pelvic floor muscle tone, erythema, infection, vaginal wall erosion, mesh protrusion, generalized atrophy.Post-operative patient treatment included repair of mesh, cystoscopy, partial removal of mesh, additional surgery, additional implant, and medication.

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 ; UK BT53 7AP
• Manufacturer (Section G): TYCO HEALTHCARE UK MANF. LTD; 20 garryduff road ; ballymoney,at BT53 7AP ; UK BT53 7AP
• Manufacturer Contact: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 14462964
• MDR Text Key: 292401482
• Report Number: 6000141-2022-00029
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: MC
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2007
• Device Model Number: IVS02
• Device Catalogue Number: IVS02
• Device Lot Number: 04H109
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/04/2022
• Date Device Manufactured: 08/31/2004
• 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
• Treatment: SURGISIS ES (RECTOCELE) (PRODUCT ID: J-SLH-4S-7X10
• Patient Outcome(s): Required Intervention; Disability
• Patient Sex: Female
• Patient Weight: 65 KG