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

Catalog Number UNKNOWN

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

Patient Problems Pain (1994); Urinary Tract Infection (2120); Injury (2348)

Event Type  Injury  

Event Description

It was reported by the patient's attorney that as a result of having the product implanted the patient experienced injury, pain, recurrent urinary tract infections, mesh erosion into urethra, 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: 10301540
• MDR Text Key: 199663840
• Report Number: 1018233-2020-04647
• 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: 07/17/2020,07/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/17/2020
• Distributor Facility Aware Date: 07/13/2020
• Event Location: Hospital
• Date Report to Manufacturer: 07/17/2020
• Date Manufacturer Received: 07/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention