MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 PELVITEX POLYPROPYLENE MESH

Catalog Number 486015

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

Patient Problems Erosion (1750); High Blood Pressure/ Hypertension (1908); Unspecified Infection (1930); Pain (1994); Abnormal Vaginal Discharge (2123); Hernia (2240); Injury (2348); Disability (2371); Prolapse (2475); Urinary Incontinence (4572)

Event Type  Injury  

Event Description

It was reported by the patient's attorney that as a result of having the product implanted the patient has experienced pain, injury, disability, and impairment.

Manufacturer Narrative

Uf/distributor report no.: (b)(4).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.

Event Description

Per additional information received via medical records on 24aug2022, the patient has experienced extrusion of mesh, pelvic pain, stress urinary incontinence, infections, bleeding or clotting disorder, cystocele, diabetes, dyspareunia, enterocele, hernias, hypertension, obesity, rectocele, vaginal infections, vaginal pain, urinary incontinence, uterine prolapse, vaginal vault prolapse, exposure of implanted vaginal mesh, vaginal discharge, diabetes mellitus and required additional surgical and non-surgical interventions.

• Brand Name: PELVITEX POLYPROPYLENE MESH
• Type of Device: PELVITEX POLYPROPYLENE MESH
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: juan velez ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 9786971
• MDR Text Key: 187848569
• Report Number: 1018233-2020-01522
• 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,Followup
• Report Date: 03/04/2020,09/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2013
• Device Catalogue Number: 486015
• 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: 02/10/2020
• Event Location: Hospital
• Date Report to Manufacturer: 03/04/2020
• Date Manufacturer Received: 08/24/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR
• Patient Sex: Female
• Patient Weight: 98 KG