MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) CONTIGEN TREATMENT SYRINGE

Catalog Number 651005

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

Patient Problems Urinary Tract Infection (2120); Urinary Frequency (2275); Dysuria (2684)

Event Type  Injury  

Event Description

It was reported in the patient's medical records that as a result of having the product implanted, the patient has experienced urinary frequency, external irritation of the outside vulva, dysuria (burning, itching with urination), recurrent urinary tract infections (enterococcus and escherichia coli), dribbling, inability to control bladder, ammonia-like smell to urine, unstable bladder with bladder irritability, overactive bladder, bladder spasm, leakage of urine with coughing, moderate cystocele, residual urinary incontinence, mixed incontinence, failed trial of vesicare, intrinsic sphincter deficiency, urge incontinence, mild-to-moderate trabeculation (cystoscopy findings (b)(6) 2010), squamous metaplasia with mild chronic inflammation of left trigone (surgical pathology (b)(6) 2010), acute kidney injury (likely due to prerenal azotemia thought related to diuretics, episodes of relative hypotension, and celebrex), urinary tract infection, chronic back pain, vulvovaginal symptoms (burning, itching, and yellowish discharge), incomplete bladder voiding, frequent nighttime urination, mild suprapubic tenderness with palpation, postmenopausal atrophic vaginitis, pelvic pressure, pain or discomfort in the lower abdomen or genital region, urine leakage associated with a strong sensation of needing to go, decreased libido, herniated lumbar disc, lumbar spinal stenosis, lumbar spine spondylosis, lumbar spine scoliosis, lumbar radicular pain, progression of lumbar degenerative changes (noted on x-ray (b)(6) 2013 - compared to (b)(6) 2009), left abdominal subcutaneous masses, diaper rash (possible allergy to diaper/pads for urine incontinence or candidiasis), chronic mild kidney disease, diabetes with renal manifestations, dermatophytosis of groin and perianal area (left groin pain with burning sensation), and yellowish discharge on adult diapers and sanitary pads with an ammonia-like odor, unspecified pain, unspecified infection, unspecified urinary problems, unspecified recurrence, dyspareunia, unspecified neuromuscular problems, vaginal scarring, unspecified "other" outcomes, and loss of consortium.The patient subsequently underwent cystourethroscopy and bladder biopsies ((b)(6) 2010); cystourethroscopy and contigen bulking agent injection to the internal sphincter x 2 ((b)(6) 2010); interstim test ((b)(6) 2012); and stage 1 interstim, stage 2 interstim, intraoperative neurophysiologic testing, and intraoperative fluoroscopy ((b)(6) 2012).

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.(b)(4).

Event Description

Per additional information received, the patient has experienced mild urethral hypermobility, urge incontinence, overactive bladder, nocturia, atrophic introitus, mild vaginal atrophy, mild introital stenosis and reported decreased libido.

• Brand Name: CONTIGEN TREATMENT SYRINGE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON); covington GA
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON); 8195 industrial blvd.; covington GA 30014
• Manufacturer Contact: angela robinson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 4381232
• MDR Text Key: 5291852
• Report Number: 1018233-2014-00368
• Device Sequence Number: 1
• Product Code: LNM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P900030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 11/05/2015

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: 12/01/2014
• Initial Date FDA Received: 12/30/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/02/2015
• 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: 75 YR
• Patient Weight: 112