MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 PELVICOL® ACELLULAR COLLAGEN MATRIX

Catalog Number 482812

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

Patient Problems Erosion (1750); Chest Pain (1776); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Urinary Frequency (2275); Prolapse (2475); Dyspareunia (4505); Urinary Incontinence (4572); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

This complaint is being opened in association with the alleged event filed by the patient¿s attorney in complaint number(s) (b)(4).There have been no allegations of deficiency or serious injury against this device.This device is listed in the patient¿s medical record.Per additional information received via medical records on 20jul2021, the patient experienced severe pain, vaginal bleeding, painful sexual intercourse, mesh erosion, cystocele, recurrent vaginal yeast infections, recurrent vaginal pain, urinary incontinence, urinary retention, uterine prolapse, vaginal vault prolapse, dyspareunia, vaginal graft exposure, urinary frequency, urinary tract infection, breast pain and required additional surgical and non-surgical interventions.

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.

Event Description

Per additional information received via medical records on 03jan2024, the patient experienced severe pain, pelvic pain, vaginal mesh exposure, vaginal bleeding, painful sexual intercourse, cystocele, recurrent or chronic vaginal or bladder infections, recurrent vaginal pain (sharp pains that feel like bad menstrual cramps, in the lower abdomen), urinary incontinence, urinary retention, uterine prolapse, vaginal vault prolapse, wound healing problems, collapsed bladder requiring additional surgical and non-surgical treatments.

• Brand Name: PELVICOL® ACELLULAR COLLAGEN MATRIX
• Type of Device: PELVICOL® ACELLULAR COLLAGEN MATRIX
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): TISSUE SCIENCE LABORATORIES; astley lane industrial estate; unit 1; swillington, leeds LS26 8XT; UK LS26 8XT
• MDR Report Key: 12272080
• MDR Text Key: 264950447
• Report Number: 1018233-2021-80057
• 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: 01/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/03/2014
• Device Catalogue Number: 482812
• Device Lot Number: 10B159
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Date Manufacturer Received: 01/03/2024
• 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: 48 YR
• Patient Sex: Female
• Patient Weight: 82 KG