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 Incontinence (1928); Urinary Tract Infection (2120); Injury (2348)

Event Type  Injury  

Event Description

The patient's attorney alleged a deficiency against the device.Per additional information received, the patient has experienced fecal incontinence, foul smelling urine, recurrent urinary tract infections, chronic back pain, sore muscles, pelvic pain, stool incontinence, abdominal scars, anal incontinence, yeast infection, vaginal dryness itching, urge incontinence ((b)(6)), vaginal pain with intercourse, severe atrophy, tender on palpation of distal mesh edge, vaginal pain, postmenopausal atrophic vaginitis, overactive bladder, foreign body, surgical excision, adhesions, vaginal mass, lesions, suture removal and partial mesh removal, filmy adhesions to the most apical aspect of the vaginal cuff, mesh erosion, pyuria, hysterectomy, peripheral nerve stimulation, urinary tract infections, and frequency.Additionally, the patient required 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: 11055473
• MDR Text Key: 223138659
• Report Number: 1018233-2020-06384
• 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: 12/21/2020,12/22/2020

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 Expiration Date: 12/01/2012
• Device Catalogue Number: 485013
• Device Lot Number: SHA00051
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/21/2020
• Distributor Facility Aware Date: 12/07/2020
• Event Location: Hospital
• Date Report to Manufacturer: 12/21/2020
• Initial Date Manufacturer Received: 12/07/2020
• Initial Date FDA Received: 12/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BARD PTFE MESH (15CM X 21 CM)
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Weight: 74