MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 URETEX SUP URETHRAL SUPPORT SYSTEM

Catalog Number 485013

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

Patient Problems Abdominal Pain (1685); Micturition Urgency (1871); Granuloma (1876); Pain (1994); Scar Tissue (2060); Abnormal Vaginal Discharge (2123); Burning Sensation (2146); Hernia (2240); Discomfort (2330); Intermenstrual Bleeding (2665); Foreign Body In Patient (2687); Dyspareunia (4505); Urinary Incontinence (4572)

Event Type  Injury  

Event Description

The patient¿s attorney alleged a deficiency against the device.Additional information has been requested, but not yet received.Product was used for therapeutic treatment.Per additional information received on february 14, 2019, the patient has experienced recurrent mechanical dysfunction of the genitourinary device, scar tissue, recurrent granulation tissue, recurrent vaginal polyps, slowing of the urinary stream, urinary urgency, polypoid reactive granulation tissue, vaginal foreign body, and granuloma.She has required multiple non-surgical interventions as well as multiple surgical interventions.Per additional information received on 11oct2021, the patient has experienced recurrent vaginal polyps, vaginal growth, urinary urgency, vaginal atrophy, urge incontinence, burning sensation while urination, urinary leakage, pain while walking, vaginal bleeding, mixed incontinence, vaginal discharge, recurrent stress urinary incontinence, vaginal spotting, recurrence of vaginal granulation tissue, discomfort in the vaginal area, pelvic pain, overactive bladder syndrome, nocturia, vaginal foreign body and granuloma, dyspareunia, pain during sexual intercourse, hernia, recurrent vaginal pain, urethral hypermobility and required additional surgical and non-surgical interventions.

• Brand Name: URETEX SUP URETHRAL SUPPORT SYSTEM
• Type of Device: URETEX SUP URETHRAL SUPPORT SYSTEM
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 12688412
• MDR Text Key: 278110318
• Report Number: 1018233-2021-80075
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 485013
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/11/2021
• Initial Date FDA Received: 10/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ALIGN® URETHRAL SUPPORT SYSTEM RETROPUBIC
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Weight: 61