MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 CONTIGEN® BARD® COLLAGEN IMPLANT

Catalog Number 651005

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

Patient Problems Muscle Spasm(s) (1966); Abnormal Vaginal Discharge (2123); Urinary Frequency (2275)

Event Type  Injury  

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." (b)(4).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.Sample not returned.

Event Description

It was reported in the patient's medical records that as a result of having the product implanted the patient has experienced debris and purulent drainage from the vagina, foul odor, buttock pain, some vaginal bleeding, urge incontinence, had eroded right and left anterior vaginal prolene sutures and an eroded and exposed vicryl suture on the left posterior side that were removed in the office between the dates of (b)(6) 2004.After this, she had some difficulty with sexual activity causing pain in her legs, was noted to have exposed pelvicol in (b)(6) 2004, had cauterization of granulation tissue in (b)(6) 2004, a rectocele to the introitus with the valsalva maneuver and had difficulty with bowel movements and a slow stream.A one inch stitch was found deep in the right cul-de-sac in (b)(6) 2008 and attempt was made in the office to cut it, but she required more invasive surgery to remove the abscessed suture in (b)(6) 2009.She had experienced shingles to the right flank and right lower abdominal quadrant during this time as well.Following this, she experienced urinary tract infections, had gallbladder surgery in 2011, a colonoscopy in 2012, abnormal vaginal bleeding, chronic pelvic pain, dyspareunia, a symptomatic grade three rectocele, an enterocele, and underwent removal of the bard vaginal mesh on (b)(6) 2014.The mesh was noted to be descending towards the ischial spines.Following this, she underwent posterior colporrhaphy, enterocele repair, sacrospinous ligament fixation, and perineorrhaphy in (b)(6) 2015 for the rectocele and enterocele using coloplast corporation axis human dermatological graft (x1) shunt.Following this, she experienced vaginal discharge, worsening urinary frequency and incontinence, anal spasm, atrophic vaginitis, midline cystocele, dyspareunia, herniation of the rectum into the vagina, nocturia, pain in the pelvis, retention of urine and urgency.She then proceeded with another implant in (b)(6) 2015 utilizing biologic human graft tension-free suburethral sling for stress urinary incontinence and then another implant in (b)(6) 2015 utilizing altis mini-sling for continued stress urinary incontinence.The patient also experienced back pain, sciatica, thyroid disease, environmental allergies, a bleeding disorder, asthma, high blood pressure and vision loss.

• Brand Name: CONTIGEN® BARD® COLLAGEN IMPLANT
• Type of Device: CONTIGEN® BARD® COLLAGEN IMPLANT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: angela robinson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 6619729
• MDR Text Key: 76947093
• Report Number: 1018233-2017-02990
• Device Sequence Number: 1
• Product Code: LNM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P900030 S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 06/07/2017

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/05/2017
• Initial Date FDA Received: 06/07/2017
• 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
• Patient Age: 56 YR