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

Model Number N/A

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

Patient Problems Micturition Urgency (1871); Urinary Retention (2119); Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

The sample was not returned.The finished product met all specifications prior to being released for general distribution.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, those 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.

Event Description

It was reported in the patient's medical records that as a result of having the product implanted, the patient has experienced abdominal pain, dyspareunia, urinary frequency, urgency, leakage, nocturia, stress incontinence, kidney stones, low back pain with a stimulator pack inserted, bladder infections, diverticulitis, suprapubic pain, substance abuse-barbituates, bladder incontinence that revealed abnormal shape of bladder neck and no sling material was seen, urinary incontinence, prescribed myrbetrique and osphena, increased sensation, low capacity.Mild chronic cervicitis, follicular/serous cysts of the ovary, suprapubic pain, pain during intercourse, strain to urinate, trial of detrol, myrbetrique, osphena and toviaz without improvement, patient states everything causes leakage, mild physiologic obstruction on the right due to an extra renal pelvis, excision of vaginal mesh performed 7-8mm of mesh was removed, tiny non-obstructing calculus noted in the right kidney (low back pain, right sided pain), urinary tract infection (uti), anxiety, bipolar depression, drug use, tobacco use (re-started), alcohol abuse, vaginal extrusion of synthetic sling anterior vaginal wall, vaginal pain and discharge, recurrence of sui, intrinsic sphincteric deficiency, hypertension, rheumatoid arthritis, irritable bowel syndrome, chronic low back pain (bulging disc lumbar region), borderline diabetic, fibromyalgia, pancreatitis, morbidly obese, ovarian cysts, pelvic inflammatory disease (pelvic pain, painful intercourse, vaginal discharge, tenderness with movement of cervix), unspecified pain, erosion, extrusion, unspecified infection, unspecified urinary problems, unspecified bowel problems, fistulae, ¿recurrence,¿ unspecified bleeding, unspecified neuromuscular problems, vaginal scarring, transvaginal excision of extruded sling material, cystoscopies (x2) transurethral collagen injection, stress urinary incontinence (sui), small cystocele, medium rectocele, urethra stricture, mixed incontinence, relaxed perineum, (b)(6) with mild (grade two) inflammatory activity, early stage two fibrosis, drug and alcohol abuse (quit 2002) and tobacco use (33 years).

Manufacturer Narrative

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
• 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: 5967306
• MDR Text Key: 55315892
• Report Number: 1018233-2016-01263
• 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,Followup
• Report Date: 09/26/2016

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 Expiration Date: 03/31/2011
• Device Model Number: N/A
• Device Catalogue Number: 651005
• Device Lot Number: CVTF0003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Device Age: 18 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/25/2014
• Initial Date FDA Received: 09/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2009
• 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: 46 YR