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 Abscess (1690); Adhesion(s) (1695); Arthritis (1723); Bacterial Infection (1735); Erosion (1750); Purulent Discharge (1812); Emotional Changes (1831); Micturition Urgency (1871); Granuloma (1876); Hemorrhage/Bleeding (1888); Incontinence (1928); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Perforation (2001); Scar Tissue (2060); Urinary Retention (2119); Abnormal Vaginal Discharge (2123); Discomfort (2330); Impaired Healing (2378); Prolapse (2475); Fluid Discharge (2686); Constipation (3274); Nodule (4551); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

(b)(4). Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803. This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda. Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report. This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report. In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿. These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting. Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms. This statement should be included with any information or report disclosed to the public under the freedom of information act. Any required fields that are unpopulated are blank because the information is currently unknown or unavailable. 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. The product was used for therapeutic treatment of urinary incontinence, uterine prolapse. It was reported that after implant, the patient experienced exposed tape on left side of vagina, skin problems, wound healing problems ¿due to autoimmune disease¿, impairment of activities, emotional changes, inflammatory mass, enterocele, granuloma/neuroma abdominal wall, pain, diverticulitis, rectocele, difficulties with bowel motions, vaginal/bladder infections, urinary incontinence, urinary retention, cystocele, dyspareunia, pelvic tumours or fibroids, recurrent vaginal pain, uterine prolapse, erosion, extrusion, protrusion, damage to pelvic organs, nerves, ligaments, tissue, vaginal vault prolapse, adhesions, scar tissue, underactive thyroid, rheumatoid arthritis, inflammatory changes, abscess, moderate streptococcus milleri gp, significantly elevated ana, whitish discharge, vaginal discharge, pulling sensation, discharge, irritable bladder symptoms, urinary urgency, discomfort/tenderness suprapubic area, postcoital bleeding, vaginitis, infection, sinus tract, swelling, nodule, incomplete bowel emptying, scarring, neuropathy. Post-operative patient treatment included revision surgery, removal of mesh, medication, hospitalization, hysterectomy, bilateral salpingo-oophorectomy, repair of enterocele, cystoscopy, posterior vaginal repair, massage therapy, removal of exposed tape on right/left side of vagina, excision of inflammatory mass, bone scan, biopsy, removal of tvt suture from left side of vagina, removal of granuloma/neuroma abdominal wall, bilateral salpingo-oophorectomy, enterocele repair and drain periurethral collections.

• 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: 14459391
• MDR Text Key: 292200052
• Report Number: 6000141-2022-00016
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/19/2022

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

• Device Expiration Date: 01/31/2006
• Device Model Number: IVS02
• Device Catalogue Number: IVS02
• Device Lot Number: 0301047-07
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/04/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 01/31/2003
• 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: 05/20/2022 Patient Sequence Number: 1