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

Catalog Number 482047

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

Patient Problems Micturition Urgency (1871); Neuropathy (1983); Pain (1994); Scar Tissue (2060); Urinary Tract Infection (2120); Injury (2348); Prolapse (2475); Fecal Incontinence (4571); Urinary Incontinence (4572); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

The patient's attorney alleged a deficiency against the device.Additional information has been requested, but not yet received.Product was used for therapeutic treatment.Per additional information received, the patient has experienced pain, urinary problems, bowel problems, recurrence, dyspareunia and neuromuscular problems.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.

Event Description

Per additional information received via medical records on (b)(6) 2022, the patient has experienced chronic pelvic pain and pressure, severe urinary tract infections, fecal incontinence, urinary urgency, perineal pain, dyspareunia, bladder pain, vaginal pain and scarring, nocturia, chronic constipation, adhesions, bowel obstruction, cystocele, dyspareunia, hernias, rectocele, uterine prolapse, vaginal vault prolapse, right side abdominal pain and required additional surgical and non-surgical interventions.

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.

• 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 Contact: juan velez ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 10804123
• MDR Text Key: 215142282
• Report Number: 1018233-2020-06340
• 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: 11/06/2020,09/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/23/2005
• Device Catalogue Number: 482047
• Device Lot Number: 02B04
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/06/2020
• Distributor Facility Aware Date: 10/30/2020
• Event Location: Hospital
• Date Report to Manufacturer: 11/06/2020
• Date Manufacturer Received: 08/26/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ETHICON TVT-O SLING
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 72 KG
• Patient Race: White