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U.S. Department of Health and Human Services

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

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C.R. BARD, INC. (COVINGTON) -1018233 URETEX SUP URETHRAL SUPPORT SYSTEM Back to Search Results
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.
 
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Brand NameURETEX SUP URETHRAL SUPPORT SYSTEM
Type of DeviceURETEX SUP URETHRAL SUPPORT SYSTEM
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key12688412
MDR Text Key278110318
Report Number1018233-2021-80075
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 10/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number485013
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received10/11/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/25/2021 Patient Sequence Number: 1
Treatment
ALIGN® URETHRAL SUPPORT SYSTEM RETROPUBIC
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