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

Model Number IVS02

Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Bacterial Infection (1735); Erosion (1750); Emotional Changes (1831); Hemorrhage/Bleeding (1888); Incontinence (1928); Unspecified Infection (1930); Muscle Weakness (1967); Internal Organ Perforation (1987); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Discomfort (2330); Obstruction/Occlusion (2422); Prolapse (2475); Hematuria (2558); Constipation (3274); Cardiovascular Insufficiency (4445); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

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 rectocele and uterine prolapse.It was reported that after the implant, the patient experienced obstruction of bladder, protrusion of mesh, chronic constipation, rectocele, vaginal infection, vaginal pain, urinary incontinence, urinary retention, vaginal vault prolapse, dyspareunia, polyps, emotional changes and disability.Post-operative patient treatment included cystoscopy, urodynamics, partial removal of mesh, colonoscopy, division of the sling to mobilize, medication, physiotherapy and tens machine every 6 months and further repair with additional mesh.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of rectocele and uterine prolapse.It was reported that after the implant, the patient experienced obstruction of bladder, protrusion of mesh, chronic co nstipation, rectocele, vaginal infection, vaginal pain, urinary incontinence, urinary retention, vaginal vault prolapse, dyspareunia, polyps, emotional changes, escherichia coli, klebsiella pneumoniae, blood in urine, leukocytes, mesh erosion, cystoceles, mesh irregular/folded, enterocele, dislodged mesh, reduced blood flow in both pudendal arteries, urinary tract infection, tenderness, vaginal bleeding, bladder neck weakness, bacterial vaginosis, fishy smell post coital, left leg weakness, pain, and disability.Post-operative patient treatment included cystoscopy, urodynamics, partial removal of mesh, colonoscopy, division of the sling to mobilize, medication, physiotherapy, imaging required, admission to hospital, mobilization of tape, tens machine every 6 months, excision of mesh erosion, vaginal repair, vaginal vault suspension, and further repair with additional mesh.

Manufacturer Narrative

Concomitant device: gynecare gynemesh ps 10x15 cm (product id: gpsl, lot no.: tpp297) additional info: a4 (weight in lbs), b2 (hospitalization), b5, b6, b7, d4 (model #, catalog #, expiration date, lot #), h10, h4, h6.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.

• 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: 14350489
• MDR Text Key: 291357681
• Report Number: 6000141-2022-00001
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 05/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2007
• Device Model Number: IVS02
• Device Catalogue Number: IVS02
• Device Lot Number: O4J169
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/04/2022
• Date Device Manufactured: 10/31/2004
• 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: SEE H10
• Patient Outcome(s): Required Intervention; Disability; Hospitalization
• Patient Sex: Female
• Patient Weight: 81 KG