MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 URETEX TRANSOBTURATOR KIT

Catalog Number 485050

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

Patient Problems Unspecified Infection (1930); Pain (1994); Urinary Tract Infection (2120); Disability (2371); Obstruction/Occlusion (2422)

Event Type  Injury  

Event Description

The patient's attorney alleged a deficiency against the device.Per additional information received via litigation the patient experienced severe pain unrelieved by analgesic medication, chronic infections, constant lower urinary tract obstruction and urinary retention, pulling sensations across the pelvic area, foul odor from vaginal area, mesh extrusion into the vagina, vaginal infections, obstruction of the bladder neck and or outlet, and additional medical intervention.

Event Description

Per additional information received, the patient experienced injury, pain, disability, impairment, infection, urinary tract infection, urinary retention, pulling sensation, foul odor, vagina infection, obstruction of bladder, additional surgical intervention and non surgical intervention.

Manufacturer Narrative

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.

Manufacturer Narrative

Correction: f2.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 TRANSOBTURATOR KIT
• Type of Device: URETEX TRANSOBTURATOR KIT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9591500
• MDR Text Key: 175059478
• Report Number: 1018233-2020-00302
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 03/04/2020,01/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2009
• Device Catalogue Number: 485050
• Device Lot Number: 24271TO
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/04/2020
• Distributor Facility Aware Date: 12/11/2020
• Event Location: Hospital
• Date Report to Manufacturer: 03/04/2020
• Date Manufacturer Received: 12/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR