MAUDE Adverse Event Report: C.R. BARD, INC. CONTIGEN BARD COLLAGEN IMPLANT TREATMENT

Catalog Number 651005

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

Patient Problems Abdominal Pain (1685); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Urinary Tract Infection (2120); Injury (2348); Blood Loss (2597)

Event Type  Injury  

Event Description

It was reported that since the product was implanted, the patient has experienced a urinary tract infection, bleeding, infections, blood clots, inability to urinate, bladder pain, abdominal pain, surgical complications, incontinence, & add'l surgical intervention.

Manufacturer Narrative

The device was not returned for evaluation.The lot number is unknown, therefore, a device history record could not be reviewed.(b)(4).

Manufacturer Narrative

The sample was not returned.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use which accompanies all devices currently addresses potential risks associated with surgically implanted materials.The instructions for use states in the adverse events: urological applications.Adverse events associated with treatment may include but are not limited to: worsened incontinence; urinary retention; urinary tract infection; and/or localized responses (including swelling, erythema, induration, infection, necrosis, abscess formation, and/or hypersensitivity response).In the clinical evaluation of contigen implant, two of the 78 treatment-related events (one event of urinary retention and one para-urethral abscess) were the result of local hypersensitivity reactions to contigen implant.In each case, the problem resolved within one month without loss of effectiveness.Urinary tract infection occurred in approximately 20% of treated patients.Urinary tract infection occurred most frequently in female patients and generally was not related to treatment.Generally, these infections resolved with appropriate antibiotic therapy and without sequelae.Urinary retention thought to result from overcorrection with contigen implant occurred in approximately 9% of patients and generally was managed with clean intermittent catheterization.Urethritis and bladder outlet obstruction occurred in approximately 2% of treated patients, and less than 2% of male patients experienced balanitis.In the clinical evaluation, approximately 7% of patients treated experienced transient worsened incontinence (1-6 months), and approximately 3% of patients treated experienced worsened incontinence which did not improve during study participation.Slight discomfort and mild bleeding will probably occur at the injection site immediately following the injection procedure.In the clinical evaluation, approximately 2% of treated patients reported pain at the injection site or injection site injury.Transient gross hematuria may occur immediately following the injection procedure.In the clinical evaluation of contigen implant, postprocedure hematuria occurred in approximately 2% of treated patients.The patient should be told to report increasing discomfort or swelling to the physician.The information provided by bard 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 bard.

• Brand Name: CONTIGEN BARD COLLAGEN IMPLANT TREATMENT
• Manufacturer (Section D): C.R. BARD, INC.; covington GA
• Manufacturer (Section G): C.R. BARD, INC.; 8195 industrial blvd.; covington GA 30014
• Manufacturer Contact: angela robinson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 4963022
• MDR Text Key: 18659868
• Report Number: 1018233-2015-00255
• Device Sequence Number: 1
• Product Code: LNM
• Combination Product (y/n): N
• PMA/PMN Number: P900030 S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,other
• Reporter Occupation: Unknown
• Type of Report: Initial,Followup
• Report Date: 10/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 651005
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/06/2015
• Initial Date FDA Received: 07/31/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention