MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 URETEX TO2 URETHRAL SUPPORT SYSTEM W/HOOK NEEDLE

Catalog Number 485054

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

Patient Problems Incontinence (1928); Injury (2348); Prolapse (2475)

Event Type  Injury  

Event Description

The patient¿s attorney alleged a deficiency against the device.Per additional information received, the patient has experienced a large enterocele, rectocele, recurrent stress urinary incontinence with intrinsic sphincter deficiency, posterior vaginal vault prolapse and required one surgical intervention.

Event Description

Na.

Manufacturer Narrative

Per email received from the fda on 11dec2020, a correction is being submitted for f2 as the initial mdr report inadvertently included the manufacture report no.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: URETEX TO2 URETHRAL SUPPORT SYSTEM W/HOOK NEEDLE
• Type of Device: URETEX TO2 URETHRAL SUPPORT SYSTEM W/HOOK NEEDLE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9086347
• MDR Text Key: 159145713
• Report Number: 1018233-2019-05766
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 09/19/2019,01/05/2021

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 Expiration Date: 11/30/2011
• Device Catalogue Number: 485054
• Device Lot Number: SGK00788
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/19/2019
• Distributor Facility Aware Date: 12/11/2020
• Event Location: Hospital
• Date Report to Manufacturer: 09/19/2019
• Initial Date Manufacturer Received: 08/27/2019
• Initial Date FDA Received: 09/19/2019
• Supplement Dates Manufacturer Received: 12/11/2020
• Supplement Dates FDA Received: 01/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Weight: 70