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

Catalog Number 482047

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

Patient Problems Incontinence (1928); Injury (2348); Foreign Body In Patient (2687)

Event Type  Injury  

Event Description

The patient¿s attorney alleged a deficiency against the device.Per additional information received via medical records the patient has experienced foreign body in patient, pelvic pain, urgency, frequency, erosion, recurrence, extrusion, infection, unspecified urinary problems, vaginal scarring (scar tissue), positive urine culture, nocturia, pyuria, abnormal urinary stream, fecal and flatus incontinence, recurrent stress incontinence, urgency of urination, urinary frequency, midline cystocele, urge incontinence, pressure, non-surgical interventions and one surgical intervention.

Event Description

Na.

Manufacturer Narrative

Correction: f2 per email received from the fda on (b)(6)2020, 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: 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
• MDR Report Key: 9208966
• MDR Text Key: 165475725
• Report Number: 1018233-2019-06599
• 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
• Report Date: 10/18/2019,01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/17/2010
• Device Catalogue Number: 482047
• Device Lot Number: 07B05-9
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/18/2019
• Distributor Facility Aware Date: 12/11/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/18/2019
• Date Manufacturer Received: 12/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MONARC TM SUBFASCIALHAMMOCK.; PELVILACE SUPPORT SYSTEM.
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Weight: 108